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[ COSMETICS & PERSONAL CARE ]
ANALYTICAL SOLUTIONS FOR COSMETICS & PERSONAL CARE
A clear path to greater product innovation, safety, and compliance
2
A NEW FORMUL A FOR SUCCESS
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[ COSMETICS & PERSONAL CARE ][ COSMETICS & PERSONAL CARE ]
COUNTERFEIT DE TEC TION 4
R AW MATERIAL S TES TING 6
FORMUL ATION 8
SAFE T Y AND REGUL ATORY TES TING 10
QUALIT Y CONTROL 12
Driven by fast-moving trends and consumers’ unending search for
novel beaut y products, the personal care and cosmetics business is
in constant motion. In an industr y where fewer than 40% of new
products succeed , the product pipeline can never be too full.
To meet your growth and prof itabilit y goals, you need to
continuously pursue accelerated innovation and ever-shor ter
product development cycles. However, there are more than
a few obstacles in your way, including:
• Growing regulator y requirements
• Increased pressure to validate product performance claims
• Consumer demand for more natural and organic products
• T he constant threat of competitive pressure
and counterfeiting.
T he answer to many of these challenges can be found
in the analy tical laborator y – and Waters solutions
can provide them, ever y step of the way.
4
COUNTERFEIT DE TEC TION: P ROT ECT ING YOUR BRAND INT EGRIT Y
According to a recent European Union study,1 counterfeiting costs the cosmetics and personal care industry $5.25 billion
annually, tens of thousands of jobs, and deprives governments of $1.9 billion in tax revenues.
For consumers, it’s not just a matter of getting swindled. Counterfeit products may even cause physical harm, as many
have been found to contain toxins and carcinogens. While luxury brands are the most frequent targets of counterfeiters,
no personal care manufacturer is immune to the problem.
For all of these reasons, companies need to be able to test samples to identify counterfeits quickly and confidently,
but catching them requires a high volume of painstaking analytical work.
Identify Counterfeit Cosmetics with Multivariate Analysis
What’s needed is a way to swiftly compare a suspect sample to the
authentic product and determine if there are differences – and if
necessary, provide a more detailed analysis in order to identify
the individual components. Waters fulfills this need with an approach
based on fast and simple multivariate analysis combining Liquid
Chromatography (LC) or Atmospheric Pressure Gas Chromatography
(APGC) with advanced time-of-flight Mass Spectrometry (MS).
Counterfeit Testing Solutions:
■ ACQUITY UPLC® I-Class System
■ UNIFI® Scientific Information System
■ Xevo® G2-XS QTof Mass Spectrometer
■ Atmospheric Pressure GC (APGC)
■ ACQUITY UPLC Columns
■ CORTECS® 1.6 µm Columns
ACQUITY I-Class System with Xevo G2-XS QTof.
1. https://oami.europa.eu/ohimportal/en/web/observatory/quantification-of-ipr-infringement
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[ COSMETICS & PERSONAL CARE ]
SOLUTION KEY FEATURES & BENEFITS:
ACQUITY UPLC I-Class System
■ The most powerful binary UPLC® system, engineered for the lowest dispersion.
■ Provides rapid, high-resolution separations to help resolve components of interest from complex matrix interference peaks.
■ Maximizes peak capacity to enhance MS sensitivity.
■ Provides the lowest carryover, complementing MS sensitivity and extending MS linear dynamic range.
Atmospheric Pressure GC (APGC)
■ Adds GC capability to Waters’ most advanced MS technologies.
■ Soft ionization means less fragmentation compared to techniques such as EI, resulting in higher sensitivity and specificity.
■ Maximizes uptime and asset utilization – changeover from UPLC to GC is quick and simple.
Xevo G2-XS QTof
■ Analyze the broadest range of compounds in the most complex samples.
■ Combines StepWave™ ion optics with the XS Collision Cell, providing a significant increase in sensitivity with no reduction in selectivity.
■ Delivers superior UPLC-compatible mass resolution, matrix-tolerant dynamic range, quantitative performance, mass accuracy, and speed of analysis – simultaneously.
UNIFI Scientific Information System
■ Merges LC and high performance MS data – both quadrupole and time-of-flight – into a single solution.
■ Encompasses data acquisition, processing, visualization, reporting, and configurable compliance tools within a networked laboratory environment.
Xevo G2-XS QTof and UNIFI Scientific Information System multivariate analysis tools used for the identification of counterfeit cosmetics.
Fake Cream Fake Lotion Fake Serum Real Cream Real Lotion Real Serum
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With Waters, cosmetics and personal care product manufacturers now have the tools to protect their revenues, their consumers’ health, and their brand’s integrity.
The key to any Waters counterfeit testing solution is the UNIFI Scientific
Information System, which includes multivariate analysis tools. These tools
enable you to reduce the multivariate dimensionality of large data sets by
using statistical modeling and principle components analysis (PCA). An initial
summary provides guidance for any further analysis that may be required, and
the resulting marker sets can be labeled as authentic or counterfeit and saved.
Subsequent samples of suspected counterfeit products can then be analyzed
and compared to the authentic marker set and quickly identified.
6
R AW MATERIAL S TES TING: ESTABL ISHING ACT ION AND SAFET Y
While the marketing department often directs the path of new cosmetic and personal care product development,
it is the responsibility of analytical laboratories to source the best raw materials and active ingredients and
determine their efficacy and safety.
The challenge is to swiftly and thoroughly characterize each ingredient and ensure product safety. That’s particularly
difficult when dealing with complex botanicals and other naturally-occurring compounds. From an analytical
perspective, it means identifying all components in a sample, developing its chemical fingerprint, pinpointing
toxins and allergens, and verifying the presence of the active ingredient in the final product.
Waters provides a wide range of technologies for screening,
isolating and quantifying raw materials and active ingredients.
Raw Material Testing Solutions:
■ Prep 100q SFC System
■ ACQUITY UPLC I-Class and H-Class Systems
■ Atmospheric Solids Analysis Probe (ASAP)
■ Xevo TQD Mass Spectrometer
■ Xevo G2-XS QTof Mass Spectrometer
■ Viridis,® XBridge® XP, XSelect® XP, and ACQUITY UPLC Columns
■ TruView™ Vials
Mass directed (m/z = 273, in source dimer) recovery of geraniol from orange oil with the Prep 100q SFC System. Sample recovery can be challenging by traditional preparative LC techniques due to the volatility of the compound. The use of supercritical fluid chromatography (SFC), which utilizes carbon dioxide as the primary mobile phase, enables up to 90% recovery for volatile compounds.
Prep 100q SFC System.
7
[ COSMETICS & PERSONAL CARE ]
SOLUTION KEY FEATURES & BENEFITS:
Prep 100q SFC System
■ Provides high-throughput, semi-preparative to preparative scale purification for higher productivity, greater flexibility, and lower costs per sample.
■ Utilizes environmentally-friendly carbon dioxide (CO2) as the primary mobile phase.
■ Purification applications include chiral and achiral separations, impurity isolation, and natural products.
■ Gas Liquid Separator (GLS) technology allows for more efficient fraction collection resulting in higher recovery of valuable compounds.
■ Fully automated open-bed sample injection and fraction collection allows for the processing of hundreds of samples, or just a few.
Atmospheric Solids Analysis Probe (ASAP)
■ Streamlines workflow by enabling rapid, direct analysis of volatile and semi-volatile solid and liquid samples in seconds.
■ Simply dip a glass capillary into the sample, place the probe into the source, and the heated nitrogen desolvation gas will vaporize the sample, with corona discharge for sample ionization.
■ Applications include the analysis of active components, such as UV absorbers in personal care products
Case Study: Advancing the Characterization and Quality Control of Botanical Extracts with Mass Spectrometry
Bio-Botanica is a leading manufacturer of 500+ quality botanical extracts.
To better identify extract constituents and meet the constant demands
of a fast-paced laboratory environment, the company implemented the
ACQUITY UPLC H-Class System with the Xevo TQD Mass Spectrometer.
Scientific and business benefits included trace-level contaminant detection,
method consolidation, reducing separation times by approximately 75%,
and the ability to identify novel compounds that may have unique
cosmetic applications.
Comprehensive characterization of botanicals with UPLC-MS/MS
8
FORMUL ATION: ENSURING PERFORMANCE AND CHARACT ERIZAT ION
New formulations are the lifeblood of the beauty industry. To keep the product pipeline full and moving steadily,
laboratory chemists need to develop formulations that consistently deliver the desired efficacy, performance,
safety, texture, fragrance, appearance, and stability – while also ensuring that the product packaging protects those
attributes over time under a broad range of environmental conditions.
To a large extent, the success of your business depends on how swiftly and efficiently you can master this process.
But there are many challenges that stand in your way, including high analytical throughput, the need to validate
label claims, regulatory limits, and the complexity of product samples.
Waters addresses these challenges with unique liquid chromatography and mass detection
technologies designed to enhance the effectiveness of your formulations laboratory.
Formulation Testing Solutions:
■ ACQUITY® Arc™
■ ACQUITY QDa® Detector
■ Viridis, XBridge XP, XSelect XP, and ACQUITY UPLC Columns
■ TruView Vials
ACQUITY Arc with ACQUITY QDa Detector.
9
[ COSMETICS & PERSONAL CARE ]
SOLUTION KEY FEATURES & BENEFITS:
ACQUITY Arc System
■ Quaternary-based LC system with the versatility and robustness required to bridge the gap between HPLC and UPLC while continuing to support validated assays.
■ Delivers true plug-and-play method compatibility and the ability to switch between HPLC and UHPLC separations.
ACQUITY QDa Detector
■ Provides mass detection data at the push of a button.
■ Pre-optimized to work with your samples, without sample-specific or user adjustments typical of traditional mass spectrometers.
■ Quantify compounds with no UV response at levels not accessible to optical detection.
■ Generate high-quality mass spectral data routinely and consistently with no special training or expertise.A mixture of six commercial biocides used in formulated shampoo and hand creams were analyzed
using the ACQUITY Arc System to evaluate the impact of both conventional HPLC and UHPLC based chromatographic separations. ACQUITY Arc offers method compatibility for HPLC and UHPLC separations to aid organizations transitioning their methods from HPLC to UHPLC.
Helping to Streamline Formulations Testing
With Waters® ACQUITY Arc System, significant productivity gains can
be realized in formulation testing by deploying a single LC platform that
allows the efficient transfer, adjustment, or improvement of methods from
any LC platform - while the ACQUITY QDa Detector provides valuable mass
spectral data within your existing workflows.
HPLC compatible:
X Bridge BEH Shield RP C18 130 A 5 µM 4.6 x 150 mm
UHPLC compatible:
CORTECS C18+, 130 A, 2.7 mM 4.6 x 150 mm
Whether you’re testing for performance or characterization, Waters provides more ways to cut time and labor-intensive steps out of the process, without sacrificing scientific rigor.
10
ACQUITY UPC2.
SAFE T Y AND REGUL ATORY TES TING: MAKING COMPL IANCE ROUT INE
Ensuring product safety is much more than a matter of fulfilling regulatory requirements. Your investments in product
quality demonstrate a commitment to consumers’ health, environmental protection, and good corporate citizenship.
Safety and regulatory testing also provide vital data to support label claims.
The continuing success of your business depends on your ability to protect your reputation as a quality brand. At the
same time, as more stringent regulations require more testing, you’re under pressure to increase laboratory throughput.
With the compliance burden only expected to grow you need a sure strategy to drive more efficient analyses.
Having served the demanding criteria of the pharmaceutical, food, and environmental industries for decades, Waters
is constantly developing innovative technologies to detect a diverse range of compounds and address ever-changing
regulatory environments.
Safety and Regulatory Testing Solutions:
■ ACQUITY UPC2® System
■ Xevo TQD
■ ACQUITY UPLC I-Class System
■ Xevo G2-XS QTof Mass Spectrometer
■ UNIFI Scientific Information System
■ ACQUITY UPC2 Trefoil™ Columns
■ ACQUITY UPC2 Torus™ Columns
■ UPC2 QC Reference Material
With Waters, regulatory compliance becomes a checklist item, not a resource-intensive obstacle.
11
[ COSMETICS & PERSONAL CARE ]
SOLUTION KEY FEATURES & BENEFITS:
ACQUITY UPC2 System
■ Combines the performance of UPLC with SFC to deliver faster separations and superior resolution for chiral and achiral applications.
■ Utilizes supercritical carbon dioxide (CO2) as the primary mobile phase to provide a more cost-effective and greener technology by reducing the use of organic solvents.
■ Streamlines sample preparation workflow by eliminating evaporation and reconstitution steps.
■ Precisely varies mobile phase strength, pressure, and temperature to fine-tune resolving power and selectivity.
■ Allows the use of gradients across the widest polarity range.
Xevo TQD Mass Spectrometer
■ Enables simultaneous acquisition of high quality quantitative and qualitative data from the widest range of experiments.
■ IntelliStart™ Technology simplifies MS setup and routine operation with automated quantification workflow tools.
■ Observe MRM (multiple reaction monitoring) data and full scan background data simultaneously for faster, more robust method development.
■ RADAR™ Technology provides the sensitivity and selectivity to monitor for sample matrix interferences, impurities, and degradants.
Faster, More Cost Effective Allergen Detection
For the analysis of allergens, our solution is the UltraPerformance Convergence
Chromatography™ (UPC2) System and Xevo TQD Mass Spectrometer. The
world’s first Convergence Chromatography system, ACQUITY UPC2 delivers a
technology based on the principles of normal-phase LC that offers the ease-of-
use of reversed-phase LC. The Xevo TQD was created to reduce the complexity
of tandem (triple) quadrupole mass spectrometry – helping to ensure maximum
productivity with minimal effort.
Rapidly Characterize Packaging Material Extracts
Likewise, the combination of the ACQUITY UPLC I-Class System, Xevo G2-XS
QTof Mass Spectrometer, and UNIFI Scientific Information System is an effective
solution for the non-targeted screening of packaging extracts. This LC-MS
methodology streamlines the structural elucidation process by utilizing MSE, an
MS/MS technique that alternates between collecting accurate mass precursor and
fragment ion information during a single analysis. This enables users to rapidly
evaluate information for an unknown component (m/z) by ranking the possible
elemental compositions and performing database searches for likely structures
ranked based on fragmentation matching.
MRM chromatograms for 26 regulated cosmetic allergens in a mixed 5-ppm calibration standard using ACQUITY UPC2 coupled with Xevo TQD.
12
QUALIT Y CONTROL : DEL IV ERING OPT IMAL P RODUCT ION VOLUME
Product success can be made or broken in production. For example, delivering a product to market can be negatively
affected by poor process control or an inability to confirm label claims.
With the US Food & Drug Administration and other regulatory bodies exerting greater influence on manufacturing
best practices (e.g., cGMP), you need tools that enable you to continuously monitor production quality and back it
up with the appropriate reports.
Waters supports Quality Control needs with systems
and software that are robust enough to handle
high-volume production at all your facilities,
from in-process monitoring to final product QC.
Quality Control Testing Solutions:
■ Empower® 3 Chromatography Software
■ ACQUITY UPLC H-Class System
■ ACQUITY UPLC PDA Detector
ACQUITY UPLC H-Class System with Photodiode Array (PDA) Detector.
13
[ COSMETICS & PERSONAL CARE ]
SOLUTION KEY FEATURES & BENEFITS:
ACQUITY UPLC H-Class System
■ Highest resolution of any quaternary LC system.
■ Improves laboratory efficiency by scaling methods to UPLC Technology.
■ Simplifies and streamlines method development workflow.
■ Future-proof labs by running existing HPLC and UHPLC methods today and transitioning to UPLC when you are ready.
Empower 3 Chromatography Data Software
■ Comprehensive control of LC, GC, MS, SFC, IC, and CE systems from a wide variety of vendors – standardize on a single platform to reduce maintenance, training, and validation costs.
■ Compliance-ready data management automates data capture and retrieval over a networked environment.
■ Empower’s QuickStart interface makes it easy to conduct targeted tasks and workflows.
■ Empower 3’s ApexTrack™ provides effective detection of poorly-resolved or low-level peaks on noisy or sloping baselines.
■ Empower Laboratory Analytics assembles and displays chromatography performance data in easy-to-view, graphical dashboards – determine which improvements are needed to increase efficiency.
■ Empower Mobile provides wireless access to Empower Software from a tablet or smart phone – monitor system status, perform routine system administration tasks, and review reports.
Empower 3 Custom Field Formula. The QC Pass/Fail criteria are based on biocide content.
Process Monitoring – Make Faster Decisions
Process monitoring of cosmetic and personal care additives during
manufacturing requires accurate and rapid decision-making information to
ensure product quality and consistency. Waters ACQUITY H-Class System,
along with the ACQUITY UPLC PDA Detector, and Empower 3 Software
provides a solution. The system can separate multiple structurally similar
biocides and UV filter agents simultaneously in a fraction of time required
for traditional HPLC – and with PDA library matching and built-in advanced
mathematical algorithms, each compound in the mixture can be identified
and quantified. In addition, Empower 3’s Custom Calculation functionality
allows the comparison of results to user/QC defined Pass/Fail criteria.
The results can be automatically flagged in a standardized report helping
to accelerate production workflow, as well as benefiting new product
development and troubleshooting.
Systems and software to support high volume production, from in-process monitoring to final product QC.
14
DATA MANAGEMENT: LEV ERAGING T HE POW ER OF INFORMAT ION
Many of the biggest challenges facing personal care and cosmetics laboratories revolve around data – capturing it,
analyzing it, managing it, and reporting it accurately. Analytical data gathered from the product development process
can also provide insights to guide future product development. Waters fulfills these needs with an array of software
solutions that allow organizations to manage increasingly large volumes of data from a broad range of analytical
techniques and make sample management and the regulatory process as efficient and error-free as possible.
LIMS CAPABILITIES WITHOUT THE COMPLEXITIES NuGenesis Lab Management System
Waters’ NuGenesis® Lab Management System is a user-centric platform that uniquely combines synergistic data, workflow,
and sample management capabilities to support the entire product lifecycle from development through manufacturing.
KEY FEATURES/BENEFITS:
■ NuGenesis SDMS automatically captures and
catalogs data generated by instruments,
scientists, and outside sources
into a centralized data repository.
■ NuGenesis ELN allows laboratories to
document observations, control
procedures, and exchange information
with other software solutions.
■ NuGenesis SampleShare is a web
client that automates the submission
of samples to NuGenesis-based
laboratories for analysis.
■ NuGenesis Stability is a stability protocol
management and testing solution that
delivers productivity improvements at
every step of the process.
■ NuGenesis Connectors provide a bi-directional link
between the NuGenesis Lab Management System
and business systems such as SAP supporting more
accurate and rapid decision-making.
SAMPLE MANAGEMENT & STABILITY
TESTINGWORKFLOW
MANAGEMENT
SOFTWAREINTEGRATION
LABORATORYINVENTORIES
ELECTRONIC LABORATORY
NOTEBOOK
SCIENTIFIC DATA
MANAGEMENTSYSTEM
SCIENTIFIC SEARCH
REGULATORYCOMPLIANCE
15
BE ASSURED. CHOOSE WATERS
GLOBAL SERVICES.
Waters Global Services focuses on optimizing Waters products with superior service, support, upgrades, training, and WatersQualityParts.®
PROVEN SATISFACTION
For 14 consecutive years, an independent quality auditing firm has ranked Waters Global Services best-in-class in providing expert technical knowledge, quick resolution of system issues, and process support.1
1. Achievement in Customer Excellence Award, Comfirmit/CustomerSat, Inc., 2007-2014; NorthFace ScoreBoard Awards,sm Omega Management Group Corporation, 2001-2006.
[ COSMETICS & PERSONAL CARE ]
Given the diversity and complexity of cosmetic and personal care product
samples, ensuring the most effective separations requires highly innovative
column chemistries. Since the formation of the company in 1958, Waters has
been developing leading-edge separation media designed for chromatography.
Our wide range of analytical columns can simplify method development,
validation, and transfer throughout your organization.
LC/UPC2 Column Technologies:
■ ACQUITY UPLC BEH and XBridge BEH HPLC Columns are based on Waters
patented organic/inorganic Hybrid Particle Technology (HPT). The second
generation HPT, known as BEH Technology,™ combines the high-pH
dissolution resistance of a polymer with the efficiency and mechanical
stability of silica. The extreme pH, temperature, and mechanical stability
of BEH Technology allows you to harness the full power of pH in UPLC,
UHPLC, and HPLC methods development.
■ XSelect HPLC Columns have alternate selectivities to the conventional
C18 or C8 phases. These chemistries are also available for UPLC under
the ACQUITY CSH™ and ACQUITY HSS product names.
■ CORTECS Columns were developed to fulfill the promise of core-shell
based chromatography phases: CORTECS 1.6 μm for maximum efficiency
of UPLC separations, and CORTECS 2.7 μm for improved speed of
analysis and flexibility for UHPLC and HPLC.
■ ACQUITY UPC2 Trefoil and Torus Column chemistries, combined with the
ACQUITY UPC2 Platform, enable separation scientists to better access
normal-phase chromatography, with the ease and reliability of reversed-
phase chromatography. They provide the ability to handle both chiral and
achiral separations with unequaled speed and unparalleled confidence.
Waters Analytical Standards and Reagents
A portfolio of differentiated and enabling standards, reference
materials, and application solutions that provide simplified
and faster workflows, along with a higher level of
confidence, quality, and repeatability in your results.
CONSUMABL ES: DRIV ING P RODUCT IV IT Y F ROM T HE START
Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 508 478 2000 F: 508 872 1990 www.waters.com
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www.waters.com/cpc
Waters, ACQUITY UPLC, UNIFI, UPLC, ACQUITY, QDa, UPC,2 Empower, NuGenesis, WatersQualityParts, XBridge, Viridis, XSelect, CORTECS, and The Science of What’s Possible are registered trademarks of Waters Corporation. StepWave, Arc, IntelliStart, UltraPerformance Convergence Chromatography, RADAR, ApexTrack, BEH Technology, CSH, Trefoil, TruView, and Torus are trademarks of Waters Corporation. All other trademarks are the property of their respective owners.
©2015 Waters Corporation. Printed in the U.S.A.December 2015 720005465EN TC-SIG