Specifications CMC Carboxymethylcellulose

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  • 8/18/2019 Specifications CMC Carboxymethylcellulose

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      PRODUCT DATA

    Hercules does not recommend any use of its products that would violate any patent or other rights. Aqualon, a Division of Hercules Incorporated

    Widnes/Uk, Rijswijk/NL, Düsseldorf/D, Le Pecq/F,Castelmaggiore (BO)/I, Tarragona/E, Warsaw/PL 

    87.510-E6(Supersedes 87.510-E5)

    Page 1 of 2March 2006

    BLANOSE  CELLULOSE GUM PH-gradepurified sodium carboxymethylcellulose 

    BLANOSE Cellulose Gum is the sodium salt of carboxymethylcellulose (CMC), manufactured to meet the purityspecifications set by the European Pharmacopoeia (EP), the United States Pharmacopeia (USP) and theNational Formulary (NF). It is made in three basic viscosity ranges, from 25 mPa.s in a 2% solution to 4500mPa.s in a 1% solution. Viscosities of some grades are shown below. Additional BLANOSE Cellulose Gum PH-types with special viscosities and other characteristics are available for special uses in, personal care,medicinal and pharmaceutical applications.

    TYPES AND TYPICAL PROPERTIES

    Degree of substitution. Method: MA 304.1506A BLANOSE Cellulose Gum PH is produced in three degrees of substitution (DS), the specification limits forwhich are listed below. Higher degrees of substitution impact the rheology of the aqueous solution and giveimproved compatibility with other solutes in the system.

    DS-Type  Substitution range  Sulphated Ash % (b)  Sodium content, % (b) 

    7 0,65 to 0,90(a)

      21.6 to 27.3 7.0 to 8.8

    9 0,80 to 0,95 25.1 to 28.3 8.1 to 9.2

    12 (for EP grades) 1,12 to 1,21 31.6 to 33.2  10.2 to 10.8

    12 (for USP grades) 1,15 to 1,45 32.1 to 37.0 10.4 to 12.0

    a) for 7S and 7O types, the lower limit of substitution is 0,80 and the upper limit of substitution is 0,95.

    b) Obtained by calculation: a reference table with calculated sulphated ash and sodium based on substitution range is available uponrequest: D 304.208.

    Viscosity ranges. Method: MA 304.1001A

    Brookfield LVF settingsDS type 7 DS type 9 DS type 12 Concentration, %

    Range at 25 C,mPa.s Spindle no RPM

    7H4F-PH 9H4F-PH 1 2500 - 4500 4 307HOF-PH 1 1000 - 2800 3 30

    7H3SF-PH 1 1000 - 2800 3 30

    7HF-PH 1 1500 - 2500 3 30

    7M31-PH 9M31F-PH 12M31P 2 1500 - 3100 3 3012M8P 2 400 - 800 2 30

    7M8SF-PH 2 200 - 800 2 30

    7MF-PH 2 400 - 600 2 30

    7M1F-PH 2 50 - 100 1 60

    7LF-PH 2 25 - 50 1 60

    This table shows selected viscosity levels. It does not mean that the material is automatically available in eachparticle size. Depending upon the technical and commercial feasibility, special grades to meet individualcustomer requirements can be made available. Please contact your technical sales representative foradditional information.

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    87.510-E6Page 2 of 2

    Particle size distributions of various BLANOSE® Cellulose Gum PH-grades. Method MA 304.1602A 

    BLANOSE Cellulose Gum PH-grades are available with different particle size distributions. Selection on whichparticle size distribution should be used depends on the final product and/or the type of equipment available todissolve BLANOSE Cellulose Gum. Particle size distributions are shown in the table below.

    Sieve openingDesignation Descript ion Limitation

    mm ASTM no.

    - regular 1 % max. on 0,600 30

    10 % max. on 0,425 40

    X fine 0,5 % max. on 0,250 60

    80 % min. thru 0,075 200

    C coarse 0 % on 1,700 12

    50 % max. on 0,850 20

    50 % max. thru 0,425 40

    15 % max. thru 0,180 80

    Other typical properties of BLANOSE Cellulose Gum PH-gradesProperty Limit Testmethod Purity, CMC content on dry basis, % 99,5 min. 100 % - (NaCl %+ Na Glycolate %)NaCl + Na Glycolate, % 0,5 max. MA 304.1501A/1502ANa Glycolate, % 0,4 max. MA 304.1502AMoisture content as packed, % 8 max MA 304.1600ABulk density, g/cm

    3  0,55-1,00 MA 304.1607A

    Solution pH, at 1% 6,5 - 8,0 MA 304.1004ATotal plate count, cfu/g 1.000 max. --Residual solvent (EP) Passes the test

    Colour and turbidity (EP) Passes the test

    Note: All methods of analysis cited are available upon request

    REGULATORY STATUSThe 7- and 9-types of BLANOSE Cellulose Gum PH-grades comply with the specifications for sodium carboxy-methylcellulose according to the current editions of the European Pharmacopoeia (EP) and the United StatesPharmacopeia (USP). BLANOSE Cellulose Gum PH-grades are produced in Alizay, France. This facilitycomplies with Current Good Manufacturing Practice Regulations (CGMPRs) as specified in the US Code ofFederal Regulations.

    PACKAGING AND STORAGEThe standard package is a 25 kg, paper bag supplied on pallets of 40 bags each. Full packaging details areavailable from Packaging Data Sheet no. 27.001-E. BLANOSE Cellulose Gum PH-grade is a non-perishable

    powder. It is recommended to use the product in rotation on a first-in first-out basis. The product should bestored under dry and clean conditions in its original packing and away from heat. The product is hygroscopic.The packaging is selected in a way to avoid ingress of moisture, but the water content of the packed productmay increase if not stored dry.

    PRODUCT SAFETYRead and understand the Safety Data Sheet (SDS) before using this product .

    CHEMICAL SUBSTANCES INFORMATIONCTFA/INCI Name : Cellulose gumCAS Number   : 9004-32-4 CAS Name  : Cellulose, Carboxymethyl ether, Sodium Salt