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SOLUTAB® A Croscarmellose Sodium - Pharma

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Chemical Name: Croscarmellose Sodium
Function: Disintegrant
Certifications & Compliance: Japan Pharmacopeia (JP), FDA IID, Kosher, European Pharmacopeia (Ph. Eur.), Halal, FSSC 22000, United States Pharmacopeia (USP), FSSAI, ISO 9001
Labeling Claims: BSE-free, Vegan, TSE-free, Halal, Kosher
Synonyms: E468, Sodium Croscarmellose
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TypeDocument Name
Technical Data Sheet
SOLUTAB® A Technical Data Sheet
SOLUTAB® A Technical Data Sheet
Technical Data Sheet
Safety Data Sheet
SOLUTAB® A Croscarmellose Sodium - Pharma Safety Data Sheet (US - EN)
SOLUTAB® A Croscarmellose Sodium - Pharma Safety Data Sheet (US - EN)
Safety Data Sheet

Knowde Enhanced TDS

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Identification & Functionality

Pharma & Nutraceuticals Functions
CAS No.
74811-65-7
EC No.
629-739-2

SOLUTAB® A Croscarmellose Sodium - Pharma Features & Benefits

Labeling Claims

Applications & Uses

Properties

Physical Form
Appearance
White fine powder
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Degree of Substitution0.60 - 0.85--
Ethanol Content (Residual Solvent)max. 0.50%-
Loss on Dryingmax. 10.0%-
pH5.0 - 7.0--
Residue on Ignition14.0 - 28.0%-
Retained on 200 Mesh (75 micron)max. 10.0%-
Settling Volume10.0 - 30.0ml-
Sodium Chloride and Sodium Glycolate Contentmax. 0.5%-
Water Soluble Substances1.0 - 10.0%-
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coliAbsentper gramPlate count
Pseudomonas aeruginosaAbsentper gram-
SalmonellaAbsentper 10g-
Staphylococcus aureusAbsentper gram-
Total Aerobic Microbial Countmax. 1000CFU/gPlate count
Total Yeasts and Moulds Countmax. 100CFU/g-

Regulatory & Compliance

Technical Details & Test Data

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Packaging & Availability

Packaging Information
  • ROQ Product Code: 106101
  • Article (SKU) Code: 106101552
  • Package Size & Type: 25 kg lined cardboard box

Storage & Handling

Storage and Handling

Store in dry area, in well-closed containers.

SOLUTAB® A Croscarmellose Sodium - Pharma
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