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Croscarmellose Sodium
CAS Number: 74811-65-7
Molecular Formula: NA
Molecular Weight: NA
Croscarmellose Sodium
Specifications of Croscarmellose Sodium USP NF Grade:
DEFINITION
Croscarmellose Sodium is the sodium salt of a cross-linked, partly O-(carboxymethylated) cellulose.
IDENTIFICATION
A. Mix 1 g with 100 mL of methylene blue solution (1 in 250,000), stir the mixture, and allow it to settle. The Croscarmellose Sodium absorbs the methylene blue and settles as a blue, fibrous mass.
B. Mix 1 g with 50 mL of water. Transfer 1 mL of the mixture to a small test-tube and add 1 mL of water and 5 drops of 1-naphthol TS. Incline the test tube, and carefully add 2 mL of sulfuric acid down the side so that it forms a lower layer: a reddish-violet color develops at the interface.
Residue on Ignition: 14.0 to 28.0%, calculated on the dried basis. Use 1.0 g for the test and use sufficient sulfuric acid to moisten the entire residue after the initial charring step, and additional sulfuric acid if an excessive amount of carbonaceous material remains after the initial complete volatilization of white fumes.
Sodium Chloride and Sodium Glycolate: To pass the test.
Acceptance criteria: The sum of the percentages of sodium chloride and sodium glycolate is NMT 0.5%.
Content of Water-Soluble Material: To pass the test.
Acceptance criteria: NMT 10.0%.
Degree of Substitution: To pass the test.
Acceptance criteria: The degree of substitution is 0.60–0.85 on the dried basis.
Loss on Drying: Dry at 105C for 6 h.
Acceptance criteria: NMT 10.0%
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count does not exceed 1000 cfu/g, and the total combined molds and yeasts count does not exceed 100 cfu/g. It meets the requirements of the test for absence of Escherichia coli.
pH: Mix 1 g with 100 mL of water for 5 min.
Acceptance criteria: 5.0–7.0
Settling Volume: To pass the test.
Acceptance criteria: The volume of the settled mass is 10.0–30.0 mL.
We also supply Croscarmellose Sodium of BP Ph Eur Grade.
Please visit SDS Safety Data Sheet of Croscarmellose Sodium Suppliers.
American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.
Suppliers and Manufacturers' Representative:
9910 Bent Oak Dr
Houston, TX 77040, USA
Call Toll Free: 1-855-55-AMMOL 1-855-552-6665
Email: info@ammol.org