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Issue 2 • 2016
Reference Materials for Jet Fuel AnalysisDiscover the Comprehensive Product Range of Paragon Scientific Ltd
pg. 3
Hexabromocyclododecane Standards
New Certified Indoor Air Calibration Set
New Analytical Standard for Vincamine
Drug Interference Mixes
New European Reference Materials (ERMs) on the Market
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Feature Article3 Reference Materials for Jet Fuel Analysis
Discover the Comprehensive Product Range of Paragon Scientific Ltd
Standards6 Hexabromocyclododecane Standards
New Analytical Standards for the Main Diastreomers of HBCD
8 New Certified Indoor Air Calibration SetOffers Increased Component Stability for Indoor Air Analysis
10 New Certified Reference Materials for ICH Q3D, USP and Ph. Eur. 5.20TraceCERT® ICP Solution Mixes for Elemental Impurities Testing
12 Trusting Your Results Means Trusting Your Reference MaterialNew Product Additional to the Organic TraceCERT® CRM Portfolio
13 New Analytical Standard for Vincamine…and Other Additions to the Phytochemical Standards Range
14 Drug Interference MixesCertified Reference Solutions for Interference Testing
17 The New IC Group of High-Quality IC-Certified Reference StandardsIC TraceCERT® Carbohydrates and Sugar Alcohols
Labware 18 NEW Timestrip® Indicators
The Smart Way to Measure Time and Temperature
NPC 19 New European Reference Materials (ERMs)
on the MarketThe IRMM has Released New CRMs for a Specific Cancer Marker and Radioactivity in Food
21 NIST Standard Reference Materials® of Ferrous MetalsMore than 100 new SRMs for steel, alloy, and cast iron analysis are available now.
Dr. Matthias Nold
Dear Customer,
In order to offer you the most comprehensive choice of analytical standards and certified reference materials on the market, our product range has been greatly expanded over the years. With numerous ISO/IEC 17025 and ISO Guide 34 accredited sites, we have immense in-house knowledge of the manufacturing of certified reference materials, reflected by a number of well-known brands such as Cerilliant, TraceCERT® and Supelco.
In addition, we also make standards and certified reference materials of renowned third party suppliers, such as pharmacopoeias (USP, PhEur) or metrological institutes (IRMM, NIST, NRC), easily available to you through our ordering system.
We are proud to include the products of UKAS-accredited CRM manufacturer Paragon Scientific as part of our offering. Paragon Scientific Ltd has more than two decades of experience in the production and certification of certified reference materials for the petrochemical industry. In the feature article of this issue of Analytix, Paul Whitehurst from Paragon Scientific Ltd will provide valuable insight into certified reference materials for jet fuel testing. I also invite you to read the other articles of this issue to familiarize yourself with our broad comprehensive product offerings of analytical reagents, standards and certified reference materials.
With kind regards,
Dr. Matthias Nold Senior Product Manager Analytical Standards [email protected]
CRMs for Jet Fuel Testing from Paragon Scientific Ltd
Analytix is published five times per year by Sigma-Aldrich Chemie GmbH, Industriestrasse 25, CH-9471 Buchs SG, Switzerland.Sigma-Aldrich Corp. is a subsidiary of Merck KGaA, Darmstadt, Germany. Publisher: Sigma-Aldrich Marketing Operations Europe Editor: Daniel Vogler
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Paul Whitehurst, Paragon Scientific Ltd
Paragon Scientific is a recognized expert in the production of premium quality Calibration Standards and Certified Reference Materials (CRMs), as demonstrated by their ISO Guide 34 and ISO/IIEC 17025 accreditations from UKAS (The United Kingdom Accreditation Service).
As part of their commitment to continually developing products and remaining at the forefront of the analytical industry, Paragon Scientific has developed a range of Calibration Standards and Certified Reference Materials specifically manufactured and certified for use in the analysis and testing of jet fuel. These products cover many of the property characteristics required for jet fuel analysis, as specified in world jet fuel specifications by issuing agencies (for example, Jointly Operated Systems (AFQRJOS), ASTM Standard Specification ASTM D1655, British Ministry of Defense Standard DEF-STAN, the International Air Transportation Association (IATA) and engine manufacturers, etc).
Jet fuel analysis depends on credible test data needed to monitor jet fuel composition, volatility, fluidity, combustion, corrosion, thermal stability, contaminants, additives and other groups of characteristics. The quality of the test data is only as good as the Calibration Standard or Certified Reference Material used to calibrate/verify the measuring equipment.
Paragon Scientific’s premium Calibration Standards and Certified Reference Materials are intended for analytical and testing laboratories to calibrate/verify measuring equipment, evaluate test procedures, and for quality control purposes for many of the jet fuel property characteristics such as Aniline Point, Color, Density, Distillation, FIA Aromatics, Flash Point, Freezing Point, Smoke Point, Sulfur, Total Acidity and Viscosity.
Aniline Point Certified Reference MaterialDetermining the aniline point is useful in characterizing pure hydrocarbons and in analyzing hydrocarbon mixtures. It is particularly informative when used in combination with other physical properties, as the aniline point serves to provide an estimate of the aromatic hydrocarbon content of mixtures.
The Aniline Point Certified Reference Material listed below is for the calibration and verification of measuring equipment used in testing petroleum and derivative products for aniline point according to ASTM D611, IP 2, and ISO 2977, and is certified under ISO Guide 34 accreditation.
Cat. No. Test Method Certified Value Package SizeCRMUAPKR ASTM D611, IP 2,
ISO 297758.48 °C 250 mL
Color Reference StandardsThe color of jet fuel serves as an indicator of product quality and processing performance throughout the industry. Therefore, the determination of color is important for quality control purposes, to check for any contamination or degradation. Darkening of the fuel or a change of color may indicate that the fuel has been contaminated and is out of specification.
Paragon Scientific offers Saybolt Color standards, ideal for validating the appearance of jet fuel. The Calibration Standards listed below are for routine calibration of color measuring equipment and verification of test data, and are certified under ISO/IEC 17025 and ISO Guide 34 accreditation.
Reference Materials for Jet Fuel AnalysisDiscover the Comprehensive Product Range of Paragon Scientific Ltd
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Cat. No. Test Method Certified Value Package Size134040 ASTM D6045, D156 -10 500 mL
134050 ASTM D6045, D156 0 500 mL
134060 ASTM D6045, D156 +12 500 mL
134070 ASTM D6045, D156 +25 500 mL
Density Certified Reference MaterialThe determination of density is a fundamental property measurement, particularly in regard to characterizing both light and heavy petroleum products. Determination of the density or relative density of petroleum and its products is necessary for the conversion of measured volumes to volumes at the standard temperature of 15 °C, which is standard practice throughout the petroleum industry.
The Density Certified Reference Material listed below is for the verification of laboratory equipment used in testing petroleum and derivative products for density according to ASTM D4052, IP 365, and ISO 12185. This product is certified under ISO/IEC 17025 and ISO Guide 34 accreditation.
Cat. No. Test Method Certified Value Package SizeCRMUDEKR ASTM D4052, IP 365,
ISO 121850.79672 g/mL 250 mL
Distillation Certified Reference MaterialThe distillation range of jet fuel is an important quality characteristic, particularly in providing information on safety and performance of the material, as well as insight into the composition and behavior of the fuel during storage and use.
The Distillation Certified Reference Material listed below is for the verification of laboratory instruments used in testing petroleum and derivative products for Distillation according to ASTM D86, IP 123, and ISO 3405. This product is certified under ISO Guide 34 accreditation.
Cat. No. Test Method Certified Value Package SizeCRMUDIKR ASTM D86, IP 123,
ISO 3405148.1 °C – 260.3 °C 250 mL
FIA Aromatics Certified Reference Material Information on aromatic hydrocarbon types is an important quality characteristic of jet fuel, particularly in the refinery and manufacturing processes. This analysis is not only useful for indicating the quality of jet fuel overall, but is also useful in characterizing the quality of petroleum fractions as blending components for motor and aviation fuels.
Paragon can offer an ISO Guide 34 FIA Aromatics Certified Reference Material for the calibration and verification of laboratory instruments used in testing petroleum and derivative products for Hydrocarbon Types in Liquid Petroleum Products by Fluorescent Indicator Adsorption according to ASTM D1319 and IP 156. This product is certified under ISO Guide 34 accreditation.
Cat. No. Test Method Certified Value Package SizeCRMU-FIKR ASTM D1319, IP 156 16.53% Volume 250 mL
Flash Point Certified Reference MaterialsFlash point is one of a number of properties that must be considered in assessing the overall flammability hazard of a material and is of particular importance in shipping and safety regulations. Flash point
measurements can indicate the possible presence of highly volatile and flammable materials in a relatively non-volatile or non-flammable material. An abnormally low flash point on a sample of kerosene could indicate a contamination of the product.
Paragon Scientific offers a range of primary Flash Point Certified Reference Materials for the verification of laboratory instruments used in testing petroleum and derivative products for flash point according to IP 170, ISO 13736 and ASTM D56. These products are certified under ISO Guide 34 accreditation.
Cat. No. Test Method Certified Value Package SizeCRMU-ABKR Abel Flash IP 170,
ISO 1373641.2 °C 250 mL
CRMU-TAKR TAG Flash ASTM D56 40.4 °C 250 mL
Freezing Point Certified Reference MaterialMaximum freezing point values are set for all aviation fuels as a guide to the lowest temperatures at which the fuel can be used without the risk of solidified hydrocarbon crystals forming. Verifying the freezing point of jet fuel is fundamental for use throughout the industry, since the presence of hydrocarbon crystals could lead to fuel starvation through clogged fuel lines or filters.
Freezing Point Certified Reference Materials from Paragon Scientific are ideal for the verification of laboratory instruments used in testing petroleum and derivative products for freezing point according to ASTM D2386 and IP 16. This product is certified under ISO Guide 34 accreditation.
Cat. No. Test Method Certified Value Package SizeCRMU-FRKR ASTM D2386, IP 16 -53.4 °C 250 mL
Mercaptan Sulfur Certified Reference Material Determination of the sulfur content of jet aviation fuel is an important quality characteristic, particularly for the use of manufacturing control purposes. Mercaptan sulfur has notable traits which need to be mitigated, including: an objectionable odor, an adverse effect on fuel system elastomers, and a tendency to be corrosive to fuel system components.
Paragon Scientific offers a Certified Reference Material for the calibration and verification of laboratory instruments used in testing petroleum, and derivative products for mercaptan sulfur content according to ASTM D3227, IP 342, and ISO 3012. This product is certified under ISO Guide 34 accreditation.
Cat. No. Test Method Certified Value Package SizeCRMUSUKR ASTM D3227, IP 342,
ISO 30120.00093 % wt 250 mL
Total Acidity Certified Reference Material The level of acidity is an important characteristic in the composition of jet fuel. Some acids can be naturally occurring in aviation turbine fuels or are present due to acid treatment during the refinery process. While significant acid contamination is unlikely, due to the number of checks that occur throughout the refining process, trace amounts of acid may be present and are undesirable as they may cause corrosion of the metal parts the fuel comes into contact with or impair the water separation characteristics of the fuel.
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Standards
As part of Paragon Scientific’s Fuels Testing range, the Certified Reference Material listed below is for the calibration and verification of laboratory instruments used in testing petroleum and derivative products for acidity in turbine engine fuel according to ASTM D3242 and IP 354. This product is certified under ISO Guide 34 accreditation.
Cat. No. Test Method Certified Value Package SizeCRMUADKR ASTM D3242, IP 354 0.0083 mg KOH/g 250 mL
Smoke Point Certified Reference Material Determination of the smoke point of jet aviation fuel is an important quality characteristic. Generally, a fuel with high aromatic content emits a smokier flame, and a high smoke point material means that the fuel will have a low smoke-producing tendency.
As part of Paragon Scientific’s Fuels Testing range, the Certified Reference Material listed below is for the calibration and verification of laboratory instruments used in testing petroleum and derivative products for smoke point according to ASTM D1322, IP 57, IP 598, and ISO 3014. This product is certified under ISO Guide 34 accreditation.
Cat. No. Test Method Certified Value Package SizeCRMUSPKR ASTM D1322, IP 57,
IP 598, ISO 301424.25 mm 250 mL
Viscosity Standards In order to provide traceability for a viscosity measurement, Viscosity Standards play a crucial role in determining accurate results. These standards are used to verify a viscometer’s constant. The determination of kinematic viscosity is an important property, primarily for safety reasons. If the fuel’s viscosity is too high then the spray droplets, when injected into the combustion section of the engine, will not be fine enough, causing problems when re-lighting the engine when in flight.
Why Choose Paragon Scientific?High quality Calibration Standards and Certified Reference Materials are only available from organizations with a robust quality system such as Paragon Scientific. ISO/IEC 17025 and ISO Guide 34 accreditation, also called the “Gold Standard”, provides credibility to the production and testing of Certified Reference Materials (CRMs) by the producer. In addition, the end users can be confident that they can rely upon the Certified Reference Material for accurate and reliable measurement results.
Paragon Scientific produces the most highly accredited Calibration Standards and Certified Reference Materials, in many cases under dual accreditation from UKAS in accordance with ISO 17025 and ISO Guide 34.
All of Paragon’s products have been manufactured to the highest certified integrity and premium quality on a global level. Every certificate provides the lowest level of uncertainty of measurement and is fully traceable to international methodology. With an excellent reputation across the industry, Paragon provides excellent customer service, technical support, and prompt delivery to all its customers.
The complete Paragon Scientific product line of Calibration Standards and Certified Reference Materials is available from Sigma-Aldrich and includes over 600 products such as Viscosity Standards, Viscometers, Density Standards, Flash Point Standards, Total Acid Number (TAN) Standards, Total Base Number (TBN) Standards, Color Standards, and Distillation Standards, among others.
For the complete portfolio, visit our website at sigma-aldrich.com/paragon
Cat. No. Test Method -20 °C Kinematic Viscosity mm2/s (cSt) -40 °C Kinematic Viscosity mm2/s (cSt) Package SizeJF1L ASTM D445, IP71 Section 1, ISO 3104 3.727 7.186 500 mL
JF1H ASTM D445, IP71 Section 1, ISO 3104 5.766 13.02 500 mL
Please note: certified values stated are nominal and can vary from batch to batch.
In regard to the measurement of jet fuel, low-temperature viscosity standards will be most applicable to the verification of jet fuel viscosity measurements. Paragon Scientific’s low-temperature viscosity standards are for the verification of glass capillary viscometers and other viscosity measuring equipment where operating temperature is controlled precisely – ideal for the analysis of jet fuel. These products are certified under ISO 17025 and ISO Guide 34 accreditation.
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Matthias Nold, Product Manager Analytical Standards
The brominated flame retardant hexabromocyclododecane (HBCD) has been widely used in industry, mainly in thermal insulation polystyrene foams and textile coatings. In addition to being present in huge quantities in many buildings, the compound is also released into the environment and can be found in biological samples throughout the world. An EU risk assessment came to the conclusion that HBCD has PBT (persistent, bioaccumulative and toxic) properties. As a consequence, it was decided to include HBCD in REACH Annex XIV as an SVHC (substance of very high concern). Since the so-called “sunset date” of August 21, 2015, HBCD is only permitted for authorized applications in the European Union. In addition, since 2013, the compound has been included in Annex A of the Stockholm Convention on Persistent Organic Pollutants (POPs). The U.S. Environmental Protection Agency (EPA) has also classified HBCD as a chemical of concern. In Japan, the compound has been banned from importation and production since 2014. Despite the restrictions on HBCD, it will still take several years until it is fully replaced by alternative flame retardants, and it will still be present in existing buildings, so monitoring of the compound in industrial goods and in the environment will be necessary. Thus, reliable reference standards are needed.
There are sixteen possible stereoisomers of HBCD, but in the technical mixture, the three isomers α, β and γ hexabromocyclododecane are predominantly present. The three isomers have different biological activities. We offer analytical chromatography standards for all three isomers as well as for the technical mixture of isomers (see Figure 1 and Table 1).
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Hexabromocyclododecane StandardsNew Analytical Standards for the Main Diastreomers of HBCD
(±)-α-Hexabromocyclododecane
Cat. No. Description Package Size51691 Hexabromocyclododecane
(mixture of isomers)50 mg
30373 (±)-α-Hexabromocyclododecane 25 mg
01986 (±)-β-Hexabromocyclododecane 25 mg
73709 (±)-γ-Hexabromocyclododecane 25 mg
Table 1. Main Stereoisomers of Hexabromocyclododecane.
Figure 1. The Three Main Isomers of Hexabromocyclododecane.
Br Br
Br
Br
BrBr
(±)-β-Hexabromocyclododecane
Br
BrBr
Br Br
Br
(±)-γ-Hexabromocyclododecane
Br Br
Br
Br
BrBr
In addition to these four HBCD standards, we offer an extensive range of standards and certified reference materials for substances of very high concern. There are currently twelve TraceCERT® CRMs for SVHCs available, manufactured under ISO/IEC 17025 and ISO Guide 34 double accreditation and certified by quantitative NMR (qNMR) (see also page 12). These products are marked with an asterisk in Table 2. The table shows all TraceCERT CRMs as well as new additions of analytical standards for SVHCs.
You can find an up-to-date list of standards and CRMs for SVHCs on the web at sigma-aldrich.com/svhc
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Standards
Are You Familiar with Our IR Product Line from Specac®?We offer products for high performance measurements within IR spectroscopy. Our selection includes:
• Quest™ and Golden Gate™ ATR units and dedicated supplies
• IR liquid sample cells and parts
• Lab pellet presses
• Film makers
For up-to-date product information, please visit sigma-aldrich.com/specac
Cat. No. Description CommentPackage
SizeNEW! 08267* Acrylamide Candidate List 100 mg
07671* Anthracene Candidate List 100 mg
79997 Azodicarboxamide Candidate List 50 mg
42438* Benzyl butyl phthalate BBP Latest application date: 08/21/2013; Sunset date: 02/21/2015 50 mg
67261* Bis (2-ethyl(hexyl)phthalate) (DEHP) Latest application date: 08/21/2013; Sunset date: 02/21/2015 100 mg
NEW! 18139* 4,4'-Diaminodiphenylmethane Latest application date: 02/21/2013; Sunset date: 08/21/2014 50 mg
18281* Dibutylphthalat (DBP) Latest application date: 08/21/2013; Sunset date: 02/21/2015 50 mg
59832* Dipentyl phthalate (DPP) Candidate List 50 mg
43540* Diisobutyl phthalate (DIBP) Candidate List 100 mg
01913* 2-Ethoxyethyl acetate Candidate List 100 mg
NEW! 80444 Heneicosafluoroundecanoic acid Candidate List 50 mg
08483 Hexahydro-4-methylphthalic anhydride, mixture of cis and trans Candidate List 50 mg
NEW! 08485 Methoxyacetic acid Candidate List 100 mg
56614* Michler’s ketone Candidate List 100 mg
06084 Nitrobenzene Candidate List 1mL
NEW! 04029* 4-Nonylphenol Candidate List 50 mg
47794 1,2,3-Trichloropropane Candidate List 100 mg
96382* Tris(2-chloroethyl) phosphate Candidate List 100 mg
Table 2. Selection of Analytical Standards and CRMs (marked with *) for ECHA Substances of Very High Concern.
For a complete list, please visit sigma-aldrich.com/svhc
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New Certified Indoor Air Calibration SetOffers Increased Component Stability for Indoor Air Analysis
Philip Pryor, Scientist R&D
Kathleen Kiefer, Senior Scientist R&D
Indoor air pollution is a term often used to describe organic chemicals that are released as gases (volatile organic compounds- VOCs) from certain solids or liquids. VOCs are carbon-based compounds that evaporate at room temperature. They may or may not have an odor. Indoor air pollution may be present in any building or home. The sources for this poor air quality include the combustion of oil, gas, kerosene, coal, wood, tobacco products, building materials and furnishings, and household cleaning and maintenance products. Some examples of the VOCs present in buildings and homes are: acetone, benzene, dichloromethane, toluene, and xylene. Concentrations in the air of these VOCs are often higher in buildings and homes than occurs outdoors.
This poor air quality may have adverse effects on human health and is known as sick building syndrome. Sick building syndrome is when the occupants of a building or home experience health issues that correlate to the time spent in the building. Long- and short-term exposure to VOCs may lead to increased health risks. Due to these potential health issues, guidelines and target compound lists have been developed for methods TO-14, TO-15, and TO-17.
In response to the growing health concerns of indoor air pollution, we have has developed a number of indoor air calibration standards. The analytical values for these certified reference materials are derived from rigorous calculations for each component (homogeneity, concentration determination, and stability assessment) to verify concentration and shelf-life.
One new indoor air standard (40353-U) is unique due to the combination of several diverse functional groups in solution. This calibration standard was initially prepared in a methanol:water (97:3) solvent system. Long-term real-time stability data indicated this formulation to be unstable. Due to excess methanol, a nucleophilic reaction occurred with nonanal and decanal, to form acetal by-products as shown in Figure 1.
These reactions occurred during long-term storage and indicated that the mixture needed to be reformulated. The new standard consists of a two-part set. The set is composed of a 48-component primary solution and a two-component secondary mix of ethyl and butyl acetate in acetonitrile. The primary solution solvent percentage was modified to methanol:water (95:5) and a proprietary stabilizing agent was added. Stability is enhanced by the water acting as both an acid and base which forms a methoxide anion. The water molecules protonate the methoxide anion and extinguish the reaction before the process of acetal formation can begin. The proprietary stabilizer and water also inhibit the formation of C9 and C10 acetals. However, it is important to note that if the standard is stored above 40 °C, heat catalysis will be capable of inducing acetal formation. The standards must be stored at the recommended temperature to reach the indicated shelf-life.
Our indoor air standards are all certified according to ISO/IEC 17025 and Guide 34 in a double-accredited laboratory. Products 40353-U and 4M7537-U are validated by GC/MS while 40369-U is validated by capillary GC/FID. Certificates for these products include a value for the gravimetric concentration, analytical concentration, and expanded uncertainty for each analyte. These standards provide the essential traceability required for quantitative measurements and enable analysts to demonstrate the accuracy of their results, execute instrument calibration, or verify their method requirements.
Figure 1. Reaction of Analytes with Methanol:Water (97:3).
R H
O
R H
H3CO OCH3CH3OH
-H2O
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Standards
Cat. No. Description Composition Concentration Package Size40353-U 40-Component Indoor
Air Standard1000 μg/mL in methanol: water (95:5)
1×1 mL
Acetone Ethanol 2-Propanol
Benzene 2-Ethyltoluene Styrene
Bromodichloromethane 3 Ethyltoluene Tetrachloroethylene
1-Butanol 4-Ethyltolutene Tetradecane
2-Butanone Heptane 1,2,4,5-Tetramethylbenzene
Chloroform Hexane Toluene
Dibromochloromethane Hexadecane Trichloroethylene
Decane (R)-(+)-Limonene Tridecane
Decanal 4-Methyl-2-pentanone 1,2,3-Trimethylbenzene
1,4-Dichlorobenzene Nonanal 1,2,4-Trimethylbenzene
1,2- Dichloroethane Nonane 1.3.5-Trimethylbenzene
Dichloromethane Octane 2,2,4-Trimethylpentane
1,2-Dichloropropane Pentadecane Undecane
2,4- Dimethylpentane (1S)--α Pinene o-Xylene
Dodecane (-)-β-Pinene m-Xylene
Ethylbenzene 1-Propanol p-Xylene
40369-U Ethyl Acetate/Butyl Acetate Solution
1000 μg/mL in Acetone 1×1 mL
Ethyl Acetate
Butyl Acetate
40397-U Indoor Air Calibration Set 1000 μg/mL in Acetonitrile 2×1 mL
40353-U 48-component Indoor Air Standard
40369-U Ethyl Acetate/Butyl Acetate Solution
New Certified Reference Materials for Marine BiotoxinsManufactured by the National Research Council of Canada (NRC)Provided as CRM Solutions or Matrix Materials
For more information, visit sigma-aldrich.com/marinetoxins
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Matthias Nold, Product Manager Analytical Standards
Pharmaceutical products may be contaminated by elemental impurities, such as residues of reagents used in their synthesis or by contamination during their processing. Therefore, elemental impurities need to be monitored. Currently, the corresponding pharmacopoeia chapters (USP 232 and Ph. Eur. 5.20) are being revised based on harmonization with the Guideline for Elemental Impurities
New Certified Reference Materials for ICH Q3D, USP and Ph. Eur. 5.20 TraceCERT® ICP Solution Mixes for Elemental Impurities Testing
(Q3D) published by the Conference on Harmonization (ICH) in December 2014 as “step 4”. 1
In the ICH Q3D guideline, every listed element has been assigned a class – 1, 2A, 2B or 3 – based on its toxicity. Also taken into account is the type of patient exposure to the drug (oral, parenteral or by inhalation) and whether the element was intentionally added during drug production. In this case, a risk assessment is needed.
ICH
Q3D
1 Co
ncen
trat
ion
Lim
its
(in m
g/kg
) Elemental Impurities Mix according to ICH Q3D oral
Elemental Impurities Mix according to ICH Q3D parenteral (new) Single-element CRM Solutions
Elem
ent
ICH
Q3D
Cla
ss
Ora
l Exp
osur
e
Pare
ntal
Exp
osur
e
Inha
latio
n Ex
posu
re Standard 1 Cat. No. 19041 in 12% HNO3
Standard 2 Cat. No. 73108 in 10% hydrochloric acid
Standard 3 Cat. No. 69729 in 5% HNO3 and HF <0.5%
Standard 1 Cat. No. 89118 in 12% HNO3
Standard 2 Cat. No. 89922 in 10% HCl
Standard 3 Cat. No. 07368 in 5% HNO3 and <0.5% HF
1 mg/L each
1000 mg/L each
10,000 mg/L each
Ag 2B 15 1 0.7 150 mg/L 10 mg/L 69389 12818 91543
As 1 1.5 1.5 0.2 15 mg/L 15 mg/L 75016 1969 67904
Au 2B 10 10 0.1 100 mg/L 100 mg/L – 38168 –
Ba 3 140 70 30 140 mg/L 70 mg/L 75017 59943 75187
Cd 1 0.5 0.2 0.2 5 mg/L 2 mg/L 12313 51994 90006
Co 2A 5 0.5 0.3 50 mg/L 5 mg/L 41798 30329 1488
Cr 3 1100 110 0.3 1100 mg/L 110 mg/L 72995 74582 93104
Cu 3 300 30 3 300 mg/L 30 mg/L 41621 68921 94459
Hg 1 3 0.3 0.1 30 mg/L 3 mg/L – 28941 75111
Ir 2B 10 1 0.1 100 mg/L 10 mg/L – – –
Li 3 55 25 2.5 55 mg/L 25 mg/L 39185 12292 90766
Mo 3 300 150 1 300 mg/L 150 mg/L 4488 68780 –
Ni 2A 20 2 0.5 200 mg/L 20 mg/L 72631 28944 19013
Os 2B 10 1 0.1 100 mg/L 10 mg/L – – –
Pb 1 0.5 0.5 0.5 5 mg/L 5 mg/L 75015 41318 39082
Pd 2B 10 1 0.1 100 mg/L 10 mg/L 42396 77091 50719
Pt 2B 10 1 0.1 100 mg/L 10 mg/L 49763 19078 74554
Rh 2B 10 1 0.1 100 mg/L 10 mg/L – 4736 –
Ru 2B 10 1 0.1 100 mg/L 10 mg/L – – –
Sb 3 120 9 2 120 mg/L 9 mg/L – 73495 91482
Se 2B 15 8 13 150 mg/L 80 mg/L 56544 50002 98838
Sn 3 600 60 6 600 mg/L 60 mg/L 63564 92615 42991
Tl 2B 0.8 0.8 0.8 8 mg/L 8 mg/L – 51873 5295
V 2A 10 1 0.1 100 mg/L 10 mg/L 75593 18399 44712
Table 1. Concentration Limits (in mg/kg) According to ICH Q3D and Suitable Multi-Element and Single-Element CRM Solutions
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Standards
For each listed element, a level for the Permitted Daily Exposure (PDE) is defined.
Based on the PDE, the maximum content limits for drug products are calculated. This results in maximum levels allowed in a drug, depending on the type of intake. Table 1 lists the corresponding limits for each type of intake: oral, parenteral and inhalation. The values are given in mg/kg and are valid for drug products with an intake of ≤10 grams per day.
ICH Q3D does not include any recommendation on instrumental methods to be used for monitoring the elements; however, ICP-OES/MS and atomic absorption spectrometry (AAS) are certainly the most common ones and are listed in both USP <233> and Ph. Eur. 2.4.20 as suitable techniques.
Last summer, we launched three TraceCERT element mixes suitable for calibration of ICP-OES, ICP-MS, or AAS instruments. The element ratios correspond to the oral concentrations of the ICH Q3D guideline mix I covers class 1, 2A and some of the 2B class elements; mix II covers the remaining 2B class elements; and mix III covers all class 3 elements. Due to big differences in the concentrations, it is not feasible to offer all elements in a single mix.
Recently, we launched a second series of three mixes covering the parenteral concentration ratios. The compositions of all six mixes currently available are also listed in Table 1.
Most of the elements are also available as single-component solution CRMS, which are also listed in Table 1.
All TraceCERT CRMs for ICP are characterized by the following features:
• Unique level of accuracy and lot-specific values
• Produced in our double-accredited laboratory that fulfills ISO/IEC 17025 and ISO Guide 34 and traceable to at least two independent references (NIST, BAM or SI unit kg)
• Sophisticated packaging and comprehensive documentation, including proper uncertainty calculation, expiration date and storage information
• Packaged in opaque and gas-tight aluminum foil bags for extended stability. Certificates are included and list up to 70 trace impurities
For more information and to view sample certificates, please visit sigma-aldrich.com/inorganiccrm
References:[1] ICH Q3D limits from Step 4 version, December 16th 2014 Option 1
(drug products with a daily dose ≤10 grams). USP and the European Pharmacopoeia commission have communicated that these limits will be adopted in corresponding USP general chapter <232> and Ph. Eur. 5.20.
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Trusting Your Results Means Trusting Your Reference Material New Product Additions to the Organic TraceCERT® CRM Portfolio
Matthias Nold, Product Manager Analytical Standards
Nowadays, the ISO/IEC 17025 accreditation has become almost indispensable for analytical testing laboratories as proof of the competence of a laboratory. Customers, authorities, and other laboratories can trust the results of an accredited lab as being reliable and comparable to values measured by other accredited labs worldwide. All aspects that are relevant to achieving reliable testing results, such as management system, method validation and training of the staff, are covered by ISO/IEC 17025.1
One very crucial aspect is the quality of the reference material used for calibration. ISO 17025 states that if possible, reference materials should be traceable to SI units or CRMs of internationally recognized sources. In the past, the lack of availability of certified reference materials with this level of traceability led to a certain leniency on this point. However, as the number of available CRMs grows rapidly, we believe that in the coming years, auditors will increasingly bring this aspect into focus – only by using a truly traceable reference material is a laboratory capable of generating traceable results.
However, the fact that most analytical techniques are structure-dependent makes the task of manufacturing traceable CRMs a very challenging one. For example, when using HPLC with UV, DAD, or Fluorescence detection, a traceable reference of the very same compound would always be needed. However, due to the infinite number of organic compounds, for most molecules, no reliable reference material can be found. Therefore, the content of an organic material is usually determined by measuring all potential impurities (such as related compounds, water, residue solvents, and inorganic impurities) and calculating the content by subtracting the impurity values from a total of 100%. With this method, if applied properly, indirect traceability to SI can be achieved. However, it implies that no potential impurities have been overlooked and that related impurities measured by chromatographic method have the same response as the target analyte.
An alternative to this laborious procedure is to use a direct relative method: a method where the chemical structure of the analyte has no influence on the quantitative result. An example of an analytical method fulfilling this is quantitative nuclear magnetic resonance spectroscopy (qNMR). While NMR has been one of the most important qualitative methods for structure elucidation of organic compounds for the past 40 years, its quantitative use has gained increasing importance over the past decade. 2 It is currently a recognized and established technique for quantification. The primary advantage of NMR is that the signal integrals are only dependent on the number of atom nuclei (in case of 1H-NMR protons) that lead to the signal. Therefore, two completely different chemical molecules can be quantitatively compared with very high precision.
The Sigma-Aldrich Merck site in Buchs (Switzerland) achieved ISO/IEC 17025 accreditation for qNMR measurements in 2009. Measurement uncertainties down to 0.1% are achieved by this lab. 3 In combination with ISO Guide 34, we are able to manufacture, under double accreditation, organic neat CRMs with traceability to NIST SRM. The portfolio of organic TraceCERT products comprises over 250 products and continues to grow at a rapid pace. The portfolio comprises the most commonly tested analytes in food and environmental analysis, ranging from pesticides, PAHs, plasticizers, and fatty acids to amino acids and natural products. The list below shows recent product additions. A complete product listing can be found at sigma-aldrich.com/organiccrm
Cat. No. Description Package Size43811 γ-Aminobutyric acid 50 mg
64148 Brombutid 50 mg
78567 Leucomalachite Green 100 mg
16677 Metronidazole 50 mg
50550 Pyrocatechin 100 mg
04029 4-tert-Octylphenol 50 mg
87780 Solvent Yellow 124 25 mg
05099 Tricaprin 50 mg
Table 1. New product additions to the TraceCERT product range
Figure 1. Selected Chemical Structures of new TraceCERT CRMs.
NH
OCH3H3C
CH3Br
H3CCH3
Brombutid
NNH3C
CH3
CH3
CH3Leucomalachite Green
NN
N
CH3
O
O CH3
CH3
H3C
Solvent Yellow 124
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Standards
Cat. No. Description Package Size49975 Acacetin 10 mg
30729 2CR-Cinchonin 50 mg
42866 Dihydromyricetin 10 mg
42776 Ginsenoside Rh4 5 mg
55836 Quercetin 3-O-rutinoside-7-O-glucoside 10 mg
75778 Vincamine 50 mg
Table 1. New Analytical Standards of Active Ingredients and Marker Substances for the Analysis of Herbal Medicinal Drugs.
Matthias Nold, Product Manager Analytical Standards
The alkaloid Vincamine, constituent of the plant vinca minor, was first isolated and described in the 1950s. It is commercially used as a drug to increase blood flow and oxygen supply to the brain.
We recently introduced a new analytical standard for Vincamine. The specification of this product includes, besides a chromatographic purity, a quantitative NMR (qNMR) value.
This product, along with the other new additions listed here, is adding to the large portfolio of analytical standards and certified reference materials for constituents of medicinal plants comprising more than 600 products so far.
You can find a complete listing of these products, including a list of the most common medicinal plants and their active ingredients by plant genus, on our website at sigma-aldrich.com/medicinalplants. You can also download or order a comprehensive brochure including product listings and selected chromatographic applications.
• Secondary standards manufactured by HWI Analytik
• Key components quantified traceable to primary pharmaceutical reference standards (content assignment by qNMR)
• HPLC method and chromatogram with peak assignment of components
Find products lists and an example certificate at sigma-aldrich.com/plantextracts
Discover a New Class of Plant Extract Reference Materials
Vincamine
NN
H3CO
O
H
CH3
OH
New Analytical Standard for Vincamine…and Other Additions to the Phytochemical Standards Range
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sigma-aldrich.com/cerilliant
Drug Interference MixesCertified Reference Solutions for Interference Testing
Maximilian Magana, Technical Marketing Specialist
Derrell Johnson, Manager, New Product Strategy and Tactical Marketing
Clinical Laboratory Improvement Amendments (CLIA) regulations require manufacturers of diagnostics and laboratory-developed tests (LDTs) to determine the effect of interfering substances during design, method development ,and validation. 1, 3 The presence of interfering substances, which often includes drugs and their metabolites, impacts measurement accuracy of the analyte of interest. 1 Interfering compounds originate from many sources, including sample matrices, contaminants inadvertently introduced during handling or sample preparation, or samples from patients on multiple drug regimens. 2, 3
The importance of identifying interfering substances is critical for numerous testing applications ranging from therapeutic drug monitoring, (confirmatory drug testing and forensic and toxicological analysis) to pharmacokinetic studies and metabolomics. Interference testing is performed during the development and validation of analytical methods to eliminate inaccurate quantification or misclassification/misidentification of target analytes.
Cerilliant offers seven interference mixes containing more than 50 of the most routinely monitored over-the-counter (OTC) and prescription drugs. These mixes may be ordered separately or together as a kit for added convenience. Cerilliant’s drug interference mixes are intended for qualitative use only in the evaluation of interferences between the mix components and target analytes of interest in a testing laboratory’s analytical method.
Visit sigma-aldrich.com/cerilliant to view Cerilliant’s extensive catalog offering of solution Certified Reference Materials.
Register at sigma-aldrich.com/registercerilliant to receive news on the latest reference standards introduced by Cerilliant.
References:[1] Burd EM. Validation of Laboratory-Developed Molecular Assays for Infectious
Diseases. Clin Microbiol Rev, 2010, 23(3), 550–576. [2] Krouwer JS. Interference Testing: Why Following Standards Is Not Always
the Right Thing to Do. J Diabetes Sci Technol, 2012, 6(5), 1182–1184. [3] McEnroe RJ, Burritt MF, Powers DM, Rheinheimer DW, Wallace BH. Interference
Testing in Clinical Chemistry; Approved Guideline—Second Edition. 2005, 25(27), 1–120.
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Standards
Cerilliant® Drug Interference Mixes (For Qualitative Use Only)Cat. No. DescriptionI-023 Drug Interference Mix 1
8 Components in Methanol, 1 mL/ampoule
Acetaminophen Caffeine (-)-Cotinine Ibuprofen
1000 μg/mL 1000 μg/mL 1000 μg/mL 1000 μg/mL
Naproxen (-)-Nicotine Phentermine R,R-(-)-Pseudoephedrine
1000 μg/mL
1000 μg/mL
100 μg/mL
100 μg/mL
I-024 Drug Interference Mix 2 5 Components in Methanol, 1 mL/ampoule
Gabapentin Pregabalin Salicylic acid
100 μg/mL 100 μg/mL 100 μg/mL
Valproic acid Vigabatrin
100 μg/mL
100 μg/mL
I-025 Drug Interference Mix 3 6 Components in Acetonitrile, 1 mL/ampoule
Aripiprazole Lacosamide Oxcarbazepine
100 μg/mL 100 μg/mL 100 μg/mL
(+)-Propoxyphene Rufinamide Warfarin
50 μg/mL
100 μg/mL
1000 μg/mL
I-026 Drug Interference Mix 4 12 Components in Methanol, 1 mL/ampoule
Alprazolam Cimetidine Citalopram HBr Clopidogrel bisulfate Clonazepam Dextromethorphan
100 μg/mL 100 μg/mL 100 μg/mL (as free base) 100 μg/mL (as free base) 100 μg/mL 50 μg/mL
Fluconazole Hydrochlorothiazide Lamotrigine Levothyroxine Methylphenidate HCl Omeprazole
100 μg/mL
100 μg/mL 100 μg/mL
5 μg/mL
100 μg/mL (as free base)
100 μg/mL
I-027 Drug Interference Mix 5 10 Components in Methanol, 1 mL/ampoule
Carbamazepine Levetiracetam Metformin HCl Phenobarbital (R)-Phenylephrine HCl
100 μg/mL 100 μg/mL 100 μg/mL (as free base) 100 μg/mL 100 μg/mL (as free base)
Phenytoin Sertraline HCl Topiramate Zolpidem tartrate Zonisamide
100 μg/mL 100 μg/mL (as free base)
100 μg/mL
100 μg/mL
100 μg/mL
I-028 Drug Interference Mix 6 8 Components in Methanol, 1 mL/ampoule
Amlodipine besylate Atorvastatin calcium salt Azithromycin Bupivacaine HCl
5 μg/mL (as free base) 100 μg/mL (as free base) 100 μg/mL (as free base) 100 μg/mL (as free base)
Cetirizine diHCl Dimenhydrinate Lisinopril Loratidine
50 μg/mL (as free base)
100 μg/mL 100 μg/mL (as free base)
100 μg/mL
I-029 Drug Interference Mix 7 6 Components in Methanol, 1 mL/ampoule
Montelukast sodium Pioglitazone HCl Prednisolone
100 μg/mL (as free base) 100 μg/mL (as free base) 100 μg/mL
Prednisone Procainamide HCl Simvastatin
50 μg/mL
100 μg/mL (as free base)
100 μg/mL
I-030 Drug Interference Mix Kit
1 ampoule of each of the listed standards 7 ampoules per kit
I-023 I-024 I-025 I-026 I-027 I-028 I-029
Drug Interference Mix 1 Drug Interference Mix 2 Drug Interference Mix 3 Drug Interference Mix 4 Drug Interference Mix 5 Drug Interference Mix 6 Drug Interference Mix 7
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Interested in Proficiency Testing (PT) or External Quality Assessment (EQA)? Register today!
PT Reporting System
Register your laboratory, submit your PT results, manage your reports, and much more. sigma-aldrich.com/pt
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Standards
The New IC Group of High-Quality IC-Certified Reference StandardsIC TraceCERT® Carbohydrates and Sugar Alcohols
Magdalena Ulman, Product Manager Analytical Reagents
Ion chromatography is a well-established method for the analysis of ionic compounds in the food and beverages consumed by people every day. Sugar is a carbohydrate that occurs naturally in many kinds of food such as milk, fruits, vegetables, cereals, and grains. Sugar is also an important nutrient that supplies energy to the body. Fructose is the sweetest sugar that one can find in nature, occurring in sweet fruits and honey. Lactose can be found in many dairy products such as cheese, butter, yogurt, and milk, which is why it is important to measure and regulate its quantity. Sugar alcohols are used in products because they give a sweet taste without the calories that sugars normally provide. Sorbitol and mannitol are commonly substituted in place of sucrose. 1–3
Quantitative analysis of certain sugars and sugar alcohols with IC is of great importance in food analysis because of their prominence as primary nutrients. A new group of IC TraceCERT carbohydrates and sugar alcohols is now available. The standards are offered in the concentration of 1000 mg/L and in HDPE 50 mL bottles.
Cat. No. Product Name Composition69222 Glucose Standard for IC C6H12O6 in water
72669 Fructose Standard for IC C6H12O6 in water
72622 Lactose Standard for IC C12H22O11 in water
69631 Sucrose Standard for IC C12H22O11 in water
72637 Galactose Standard for IC C6H12O6 in water
69755 Sorbitol Standard for IC C6H14O6 in water
69714 Mannitol Standard for IC C6H14O6 in water
72619 Glycerol Standard for IC HOCH2CH(OH)CH2OH in water
72561 Xylitol Standard for IC HOCH2[CH(OH)]3CH2OH in water
Please visit our website for more information: sigma-aldrich.com/ic
References:[1] Brown, S. R.; Schnute, W. C.; Miller, M.; and Wang, J. (L.) Specific and Selective
Detection for Food and Beverage Analysis by Ion Chromatography-Mass Spectrometric Detection. Thermo Fisher Scientific 2011.
[2] Bruce, J. The Analysis of Sugars Using Ion Chromatography, Metrohm (UK) 2002.
[3] Suksom, W.; Wannachai, W.; Boonchiangma, S.; Chanthai, S.; Srijaranai, S. Ion Chromatographic Analysis of Monosaccharides and Disaccharides in Raw Sugar, Chromatographia, 2015, 78, 873–879
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sigma-aldrich.com/timestrip
NEW Timestrip® Indicators The Smart Way to Measure Time and Temperature
Daniel Weibel, Product Manager Analytical Reagents
In this seventh article about Timestrip smart indicators (1-5: 2015 and 1: 2016), we focus on two of the six new variants recently added to the catalog.
Get Control of Temperature with the Timestrip® Food Temp™ Range
Food and seafood wholesalers, retailers, and caterers are facing increased regulation of cold chain transport and require monitoring solutions for temperature reassurance and audits. The Food Temp range of the Timestrip analog temperature indicator offers the most user-friendly, relevant, and cost-effective monitoring solution of its type.
Two variants, Food and Seafood, can be ordered from the catalog. Once activated, each one monitors temperature and indicates only if cumulative breaches of 5 °C (Food) or 3 °C (Seafood) have reached a minimum of 2 hours. Monitoring then continues with further breaches recorded up to a maximum of 4 hours (Figure 1).
ApplicationsThe Food Temp range has widespread applications, including:
• Fresh seafood and produce transport
• Shipment of restaurant food samples to laboratories for testing
• Catering: airline and train, school meals, lunch boxes, home delivery, restaurants
• Premium food retailing, hub and spoke production
Cat. No. Description NEW 06732 Timestrip Seafood
NEW 07475 Timestrip Food
NEW 89148 Timestrip 1 hour
NEW 88790 Timestrip 7 days
NEW 80956 Timestrip 12 hours
NEW 80826 Timestrip PLUS 8 °C 48 hours
93064 Timestrip 1 month
07603 Timestrip 3 months
03849 Timestrip 3 months, key chain
06797 Timestrip 6 months
74831 Timestrip 12 months
06929 Timestrip 12 months, key chain
06693 Timestrip Plus -20 °C
92210 Timestrip Plus 0 °C
08168 Timestrip Plus 8 °C
92451 Timestrip Plus 25 °C
80474 Timestrip Plus 30 °C
80476 Timestrip Plus Duo 10 °C and 34 °C
Table 1. Each Timestrip is Available in the Following Package Sizes: 10EA, 100EA, 500EA.
Timestrip Seafood 3 °C threshold
Timestrip Food 5 °C threshold
Figure 1. Activation of a Timestrip Food Indicator.
Features & BenefitsFood and Seafood Timestrips are small (19×30 mm), self-adhesive labels that can be attached to individual packets or shipments. They can be stored at room temperature and activated only when needed. Each label has a unique number for traceability, breach indication is irreversible, and they can be easily and immediately interpreted by the receiver of the shipment.
With Timestrip custom solutions you can even design your own Food Temp indicator subject to minimum order quantities. Choose your temperature threshold, time markers and graphics.
For more information on Timestrip, visit our web portal at sigma-aldrich.com/timestrip or contact [email protected]
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NPC
New European Reference Materials (ERMs) on the Market The IRMM has Released New CRMs for a Specific Cancer Marker and Radioactivity in FoodJens Boertz, Product Manager Analytical Reagents
The Institute for Reference Materials and Measurements (IRMM) is one of the seven institutes of the Joint Research Centre (JRC), a Directorate-General of the European Commission (EC). One objective of IRMM is the support of EU policies with scientific advice concerning measurements and standards, such as the development of reference methods or certified reference materials. The reference materials of JRC-IRMM cover several areas, such as clinical chemistry, the environment, genetically modified organisms (GMOs), industrial raw materials, occupational hygiene and physical properties, as well as food and agriculture.
GMO-certified Reference Materials for DP-ØØ4114-3 Maize ReleasedGenetically modified organisms (GMOs) need to be authorized before they are allowed to enter the European market. The availability of a reference material and a validated method, together with the risk assessment, are prerequisites for a possible authorization of DP-ØØ4114-3 maize event for the European market.
DuPont Pioneer (U.S.) developed the genetically modified 4114 maize event (unique identifier code DP-ØØ4114-3) as a transgenic insect-resistant and herbicide-tolerant crop. The event contains four transgenes, which confer resistance to certain lepidopteran and coleopteran pests, as well as tolerance to the herbicide phosphinothricin (glufosinate).
Pioneer commissioned the JJRC-IRMM to produce a certified reference material (CRM) for the quantification of this 4114 maize event.
A set of five CRMs: (ERMBF439A, B, C, D and E, certified for their DP-ØØ4114-3 maize mass fractions), has now been released.
These reference materials will enable GMO testing laboratories to quantify 4114 maize event in food and feed products and to implement the labeling threshold for food and feed according to regulations (EC) No. 1829/2003 and (EC) No. 619/2011.
Release of New Reference Material for a Specific Cancer MarkerJRC scientists have characterized and certified the mass concentration of the cancer marker beta-2-microglobulin as an additional parameter in the certified reference material for proteins in human serum. This work was done in close collaboration with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) for the standardization of measurements of proteins.
The detection and quantification of beta-2-microglobulin is important for the diagnosis and monitoring of multiple myeloma and lymphoma. The levels of beta-2-microglobulin and albumin in serum samples are used to classify patients into prognostic groups (including medial survival rates). Despite the current use of this system in routine analysis, discrepancies were highlighted between results from different laboratories, leading to difficulties for implementing the prognosis. For the same reason, the EU Directive on In Vitro Diagnostic Medical Devices (IVD-MD) (Directive 98/79/EC) demands traceability of calibrants and control materials to common reference measurement procedures and/or reference materials of higher order.
Therefore, the reference material ERM®-DA470k/IFCC was produced, characterized and certified for beta-2-microglobulin in accordance with ISO Guide 34. An inter-laboratory comparison was performed with adherence to the quality requirements of ISO/IEC 17025. Details of the work are described in the additional certification report, available together with the certificate in our online catalog.
Read more about the certification of beta-2-microglobulin in ERMDA470 in the certification report.
ERMEB074 and ERMEB075 – Testing the Quality of CopperGiven its physical and chemical properties (ductility, excellent thermal and electrical conductivity, corrosion resistance) and its high antimicrobial activity, copper is used in many sectors and industries: building construction, power generation and transmission, electronic product manufacturing, production of industrial machinery and the transportation sector.
The demand for refined copper was estimated at 0.5 million tons in 1900 and was 20 million tons in 2012. The price of copper reflects the function of its impurity levels with premiums being paid for very low impurity levels and penalties for high impurity levels. The copper market is an important globalized market, which drives the need for international standardization.
With only 5% of copper production and approximately 20% of worldwide use, Europe depends on imports of this crucial commodity. To support European and world trade and to strengthen competition
© European Communities, 2015
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in the field, JRC-IRMM has produced a suite of certified reference materials (CRMs) for testing metal impurities in copper.
Pure copper was spiked with impurities at two different levels and machined into discs, rods, and chips, with each form being best suited to specific analytical methods for the determination of trace elements in copper. Each form was then packaged and made available for distribution. Extensive homogeneity studies demonstrated that the trace metal content at each level was homogeneous across forms and units.
The certified values were assigned based on the results from an inter-laboratory comparison, involving laboratories of demonstrated competence. Fifteen laboratories from the EU, USA, and Canada determined the trace metal content using 12 different analytical methods. After technical and statistical evaluation and a multi-step peer-review process, certified values and their uncertainties were assigned:
• For the low-level materials ERMEB074A, B and C, certified values for 20 elements and indicative values for another 5 elements were assigned. For the high-level materials ERMEB075A, B and C, certified values for 24 elements and indicative values for another three elements were assigned
The whole project was conducted in line with JRC-IRMM’s accreditation for the production of reference materials. A detailed report is available via our web catalog.
JRC-IRMM Releases its First Reference Material Certified for Radioactivity in a Food Matrix IRMM426JRC-IRMM has developed and released the first fruit matrix reference material (IRMM 426 Wild Berries) certified for the two most important anthropogenic (man-made) radionuclides, 137Cs and 90Sr, and for the natural 40K. This reference material supports the precise measurement of radionuclides in agricultural products.
The 2011 accident in the Fukushima Daiichi nuclear power plant resulting from the preceding earthquake and tsunami, underlined the need for reference materials of radionuclides in food to support accurate measurements as a basis for making undisputable decisions on radiological protection. Reference materials are needed for many types of food, and dried bilberry material may serve as a representative for vegetables and fruit, in particular, as it is not possible to make reference materials of every possible type of food.
Bilberry samples were collected in a region close to the Chernobyl reactor site, but outside the exclusion zone. Due to natural uptake from elevated levels in the environment, the radionuclides 90Sr and 137Cs were metabolized by the plants. The elevated levels of 137Cs and, in particular, 90Sr are below the exemption levels, allowing free transport and easy laboratory handling of the material. The material was processed at JRC-IRMM by oven-drying, cryo-milling, sieving and homogenization; it was finally bottled in units of approximately 100 g. The material was sterilized by gamma-irradiation against degradation.
The certified values of IRMM426 are traceable to the SI units (Bq and kg) and were established by nine laboratories from national metrology institutes, the IAEA and JRC-IRMM.
The new reference material IRMM426 was processed, characterized and certified in accordance with ISO Guide 34. Details about material sampling, processing, characterization and certification are described in the certification report, available together with the certificate online.
Cat. No. Description Certified PropertyERMAD482 Ruminant pDNA calibrant DNA sequence
ERMAD483 Porcine pDNA calibrant DNA sequence
ERMEC680M Polyethylene Element content
ERMEC681M Polyethylene Element content
ERMBF439A DP-004114-3 maize GMO mass fraction
ERMBF439B DP-004114-3 maize GMO mass fraction
ERMBF439C DP-004114-3 maize GMO mass fraction
ERMBF439D DP-004114-3 maize GMO mass fraction
ERMBF439E DP-004114-3 maize GMO mass fraction
ERMBF438A VCO-01981-5 maize GMO mass fraction
ERMBF438B VCO-01981-5 maize GMO mass fraction
ERMBF438C VCO-01981-5 maize GMO mass fraction
ERMBF438D VCO-01981-5 maize GMO mass fraction
ERMBF438E VCO-01981-5 maizeE GMO mass fraction
IRMM426 Wild Berries Isotope amount content
IRMM427 Pike Perch Organic pollutants
IRMM428 Water Organic pollutants
ERMEF001 Biodiesel Element content
ERMEB074A Electrolytic copper Element content
ERMEB074B Electrolytic copper Element content
ERMEB074C Electrolytic copper Element content
ERMEB075A Electrolytic copper with added impurities
Element content
ERMEB075B Electrolytic copper with added impurities
Element content
ERMEB075C Electrolytic copper with added impurities
Element content
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NPC
NIST Standard Reference Materials® of Ferrous Metals More than 100 new SRMs for steel, alloy, and cast iron analysis are available now
Jens Boertz, Product Manager Analytical Reagents
The National Institute for Standards and Technology (NIST) is one of the oldest physical science laboratories in the U.S. The U.S. Congress established the agency to remove a major handicap to U.S. industrial competitiveness at the time – a second-rate measurement infrastructure that lagged behind the capabilities of England, Germany, and other economic rivals. Today, NIST measurements support the smallest of technologies – nanoscale devices so tiny that tens of thousands can fit on the end of a single human hair – to the largest and most complex of human creations, from earthquake-resistant skyscrapers to wide-body jetliners to global communication networks.
We are proud to be the first licensed distributor of NIST Standard Reference Materials. The following tables provide an overview of ferrous SRMs certified for element content currently available.
The up-to-date list of all SRMs can be found at sigma-aldrich.com/nist
Plain Carbon Steels (chip form)Cat. No. SRM Code Description Pkg SizeNIST8K SRM 8K Bessemer steel (simulated)
0.1% carbon150 G
NIST12H SRM 12H Basic Open-Hearth Steel 0.4% Carbon
150 G
NIST13G SRM 13G Carbon Steel, 0.6% 150 G
NIST14G SRM 14G Carbon Steel, (AISI 1078) 150 G
NIST16F SRM 16F Basic Open-Hearth Steel 1% Carbon
150 G
NIST19H SRM 19H Basic Electric Steel 0.2% Carbon 150 G
NIST20G SRM 20G AISI 1045 steel 150 G
NIST152A SRM 152A Basic Open-Hearth Steel 0.5% Carbon (Tin Bearing)
150 G
NIST178 SRM 178 0.4C Basic Oxygen Furnace Steel 150 G
NIST368 SRM 368 Steel (AISI 1211) 150 G
Low Alloy Steels (chip form)Cat. No. SRM Code Description Pkg SizeNIST30F SRM 30F Cr-V Steel (SAE 6150) 150 G
NIST32E SRM 32E LA Steel, Ni-Cr (SAE 3140) 150 G
NIST33E SRM 33E Nickel Steel 150 G
NIST36B SRM 36B LA Steel, Cr-Mo 150 G
NIST72G SRM 72G Low Alloy Steel (AISI 4130) 150 G
NIST100B SRM 100B Manganese Steel 150 G
NIST106B SRM 106B LA Steel, Cr-Mo-Al (Nitralloy rG) 150 G
NIST125B SRM 125B LA Steel High Silicon 100 G
NIST129C SRM 129C LA Steel, High Sulfur (SAE 112) 150 G
NIST139B SRM 139B Chromium-Nickel-Molybdenum Steel
150 G
NIST155 SRM 155 Chromium-Tungsten Steel 150 G
NIST163 SRM 163 Chromium Steel 100 G
NIST179 SRM 179 LA Steel, High Silicon 150 G
NIST291 SRM 291 Cr-Mo Steel (ASTM A-213) 150 G
NIST293 SRM 293 Cr-Ni-Mo (AISI 8620) 150 G
NIST2171 SRM 2171 LA Steel (HSLA 100) 150 G
Special Low Alloy Steels (chip and pin forms)Cat. No. SRM Code Description Pkg SizeNIST361 SRM 361 LA Steel (AISI 4340) 150 G
NIST363 SRM 363 LA Steel, Cr-V (mod.) 150 G
NIST364 SRM 364 LA Steel, High C (mod.) 150 G
NIST2159 SRM 2159 LA Steel, Carbon & Sulfur Only 150 G
NIST2160 SRM 2160 LA Steel, Carbon & Sulfur only 150 G
NIST2165 SRM 2165 Low Alloy Steel 150 G
NIST2166 SRM 2166 LA Steel, F 150 G
NIST2167 SRM 2167 Low Alloy Steel 150 G
NIST2168 SRM 2168 High Purity Iron 150 G
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High Alloy Steels (chip form)Cat. No. SRM Code Description Pkg SizeNIST126C SRM 126C High Alloy Steel, High Nickel 150 G
NIST344 SRM 344 15 Chromium-7 Nickel Steel (Mo Precipitation Hardening)
150 G
NIST346A SRM 346A Valve Steel 150 G
NIST862 SRM 862 High-Temperature Alloy L 605 150 G
NIST868 SRM 868 High Temp Alloy Fe-Ni-Co 150 G
Gases in Ferrous Metals (rod and disk form)Cat. No. SRM Code Description Pkg SizeNIST1089 SRM 1089 Steels, Set (consists of SRMs 1095,
1096, 1097, 1098 and 1099)SET
NIST1090 SRM 1090 Oxygen in Ingrot Iron ROD
NIST1091A SRM 1091A Oxygen in Stainless Steel (AISI 431) ROD
NIST1093 SRM 1093 Oxygen in Valve Steel ROD
NIST1094 SRM 1094 Oxygen in Maraging Steel ROD
NIST1754 SRM 1754 Low-Alloy Steel, AISI 4320 ROD
NIST1755 SRM 1755 Nitrogen in Low Alloy Steel DISK
Stainless Steels (chip form)Cat. No. SRM Code Description Pkg SizeNIST73C SRM 73C Stainless Steel, Cr (SAE 420) 150 G
NIST101G SRM 101G Stainless Steel (AISI 304L) 100 G
NIST123C SRM 123C Stainless Steel Cr-Ni-Nb (AISI 348) 150 G
NIST160B SRM 160B Stainless Steel Cr-Ni-Mo (AISI 316) 150 G
NIST166C SRM 166C Stainless Steel, Low-Carbon (AISI 316L)
100 G
NIST339 SRM 339 17 Chromium-9 nickel-0.2 selenium steel
150 G
NIST343A SRM 343A Stainless Steel (AISI 431) 150 G
NIST893 SRM 893 Stainless Steel (SAE 405) 150 G
NIST895 SRM 895 Stainless Steel (SAE 201) 150 G
Tool Steels (chip form)Cat. No. SRM Code Description Pkg SizeNIST50C SRM 50C Tungsten-Chromium-
Vanadium Steel150 G
NIST132B SRM 132B Tool steel (AISI M2) 150 G
NIST134A SRM 134A Molybdenum-Tungsten-Chromium-Vanadium Steel
150 G
NIST2172 SRM 2172 S-7 Tool Steel 150 G
Low Alloy Steels (disk and rod forms)Cat. No. SRM Code Description Pkg SizeNIST663 SRM 663 Chromium-Vanadium Steel
(Modified)5 RODS
NIST665 SRM 665 Electrolytic Iron 5 RODS
NIST1134 SRM 1134 LA Steel, High Silicon DISK
NIST1135 SRM 1135 LA Steel, High Silicon DISK
NIST1218 SRM 1218 LA Steel, High Silicon DISK
NIST1224 SRM 1224 LA Steel, Carbon (AISI 1078) DISK
NIST1225 SRM 1225 LA Steel AISI 4130 DISK
NIST1226 SRM 1226 LA Steel DISK
NIST1227 SRM 1227 LA Steel, Basic Open Hearth, 1% C DISK
NIST1228 SRM 1228 LA Steel 0.1% C DISK
NIST1264A SRM 1264A LA Steel, High Carbon (mod.) DISK
NIST1265A SRM 1265A Electrolytic Iron DISK
NIST1269 SRM 1269 Line Pipe (AISI 1526 mod) DISK
NIST1270 SRM 1270 LA Steel, Cr-Mo (A336) (F-22) DISK
NIST1271 SRM 1271 LA Steel (HSLA-100) DISK
NIST1286 SRM 1286 Low Alloy Steel (HY 80) DISK
NIST1761A SRM 1761A Low Alloy Steel DISK
NIST1762A SRM 1762A Low Alloy Steel DISK
NIST1763A SRM 1763A Low Alloy Steel DISK
NIST1764A SRM 1764A Low Alloy Steel DISK
NIST1765 SRM 1765 Low Alloy Steel DISK
NIST1766 SRM 1766 Low Alloy Steel DISK
NIST1767 SRM 1767 Low Alloy Steel DISK
NIST1768 SRM 1768 High-Purity Iron DISK
High-Temperature Alloys (chip and disk forms)Cat. No. SRM Code Description Pkg SizeNIST866 SRM 866 Incoloy 800 100 G
NIST867 SRM 867 Incoloy, 825 100 G
NIST1230 SRM 1230 High-Temperature Alloy A286 DISK
NIST1246 SRM 1246 Incoloy 800 DISK
NIST1247 SRM 1247 Incoloy 825 DISK
NIST1250 SRM 1250 High Temp. Alloy Fe-Ni-Co DISK
NISTC2400 SRM C2400 High-Alloy Steel ACI (17/4 PH) DISK
NISTC2401 SRM C2401 HA Steel (ACI-C-4M-Cu) DISK
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Stainless Steels (disk form)Cat. No. SRM Code Description Pkg SizeNIST1155A SRM 1155A Stainless Steel (Cr 18 Ni 12 Mo 2) DISK
NIST1171 SRM 1171 Stainless Steel Cr17-Ni11-Ti0.3 AISI 321
DISK
NIST1172 SRM 1172 Stainless Steel Cr 17-Ni 11-Nb 0.6 (AISI 348)
DISK
NIST1219 SRM 1219 Cr16-Ni2 (AISI 431) DISK
NIST 1223 SRM 1223 Chromium Steel DISK
NIST 1295 SRM 1295 Stainless Steel (SAE 405) DISK
NIST1297 SRM 1297 Stainless Steel (SAE 201) DISK
NIST C1151A SRM C1151A Stainless Steel 23Cr-7Ni DISK
NIST C1152A SRM C1152A Stainless Steel 18Cr-11Ni DISK
NIST C1153A SRM C1153A Stainless Steel 17Cr-9Ni DISK
NIST C1154A SRM C1154A Stainless Steel 19Cr-13Ni DISK
NIST C1296 SRM C1296 Stainless Steel DISK
Speciality Steels (disk form)Cat. No. SRM Code Description Pkg SizeNIST1157 SRM 1157 Tool Steel (AISI M2) DISK
NIST1158 SRM 1158 High-Nickel Steel (36% Ni) DISK
NIST1772 SRM 1772 Tool Steel (S-7) DISK
Steelmaking Alloys (powder form)Cat. No. SRM Code Description Pkg SizeNIST57B SRM 57B Silicon Metal 40 G
NIST58A SRM 58A Ferrosilicon (73% Si) 75 G
NIST59A SRM 59A Ferrosilicon 50 G
NIST64C SRM 64C Ferrochromium, High Carbon 100 G
NIST68C SRM 68C Ferromanganese, High Carbon 100 G
NIST90 SRM 90 Ferrophosphorus 75 G
NIST195 SRM 195 Ferrosilicon (75% Si-HP Grade) 75 G
NIST196 SRM 196 Ferrochromium, (Low-Carbon) 100 G
NIST689 SRM 689 Ferrochromium Silicon 100 G
Cast Irons (chip form)Cat. No. SRM Code Description Pkg SizeNIST4L SRM 4L Cast Iron 150 G
NIST6G SRM 6G Cast Iron 150 G
NIST82B SRM 82B Nickel-Chromium Cast Iron 150 G
NIST107C SRM 107C Cast Iron (Ni-Cr-Mo) 150 G
NIST115A SRM 115A Copper-Nickel-Chromium Cast Iron 150 G
NIST122I SRM 122I Cast Iron 150 G
NIST334 SRM 334 Gray Cast Iron 150 G
NIST338 SRM 338 White Cast Iron (Carbon & Sulfur) 150 G
NIST341 SRM 341 Ductile Cast Iron 150 G
NIST342A SRM 342A Nodular Cast Iron 150 G
NIST892 SRM 892 High-Alloy White Cast Iron (Ni-Hard, Type IV)
150 G
Cast Steels, White Cast Irons, and Ductile Irons (disk form)Cat. No. SRM Code Description Pkg SizeNIST1138A SRM 4L Cast Iron 150 G
NIST1139A SRM 6G Cast Iron 150 G
NIST1173 SRM 82B Nickel-Chromium Cast Iron 150 G
NISTC 1137A SRM 107C Cast Iron (Ni-Cr-Mo) 150 G
NISTC 1145A SRM 115A Copper-Nickel-Chromium Cast Iron 150 G
NISTC1173 SRM 122I Cast Iron 150 G
NISTC1290 SRM 334 Gray Cast Iron 150 G
NISTC1291 SRM 338 White Cast Iron (Carbon & Sulfur) 150 G
NISTC1292 SRM 341 Ductile Cast Iron 150 G
NISTC2424 SRM 342A Nodular Cast Iron 150 G
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