Croscarmellose Sodium

Croscarmellose or sodium Sodium croscarmellose is an internally cross-linked sodium carboxymethylcellulose for use as a superdisintegrant in pharmaceutical formulations and other uses. Croscarmellose sodium, or sodium CMC, is a cross-linked polymer of carboxymethylcellulose sodium. It appears as white, fibrous, free-flowing powder, and is used commonly as an FDA-approved disintegrant in pharmaceutical manufacturing. E468 is the E number of crosslinked sodium carboxymethyl cellulose, used in food as an emulsifier. The cross-linking reduces water solubility while still allowing the material to swell (like a sponge) and absorb many times its weight in water. As a result, it provides superior drug dissolution and disintegration characteristics, thus improving formulas' subsequent bioavailability by bringing the active ingredients into better contact with bodily fluids.

General Properties and Specifications of Sodium Croscarmellose or Croscarmellose Sodium:
Appearance: White, fibrous, free-flowing powder.
Odor: Oderless.
pH: 5.0 ~ 7.0
Loss on drying: NMT 10.0%
Na-chloride & Na-glucolate: NMT 0.5%
Heavy metals: NMT 10ppm
Water-soluble substances: NMT 10.0%.

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%–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.
Packaging and Storage: Preserve in well-closed containers. No storage requirements specified.

Specifications of Croscarmellose Sodium BP Ph Eur:
Action and use: Excipient.

DEFINITION
Cross-linked sodium carboxymethylcellulose.
Sodium salt of a cross-linked, partly O-carboxymethylated cellulose.

CHARACTERS
Appearance: White or greyish-white, hygroscopic powder.
Solubility: Practically insoluble in acetone, in anhydrous ethanol and in toluene.

IDENTIFICATION
A. Mix 1 g with 100 mL of a solution containing 4 ppm of methylene blue, stir the mixture and allow it to settle. The substance to be examined 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 0.05 mL of a freshly prepared 40 g/L solution of α-naphthol in methanol. 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 colour develops at the interface.
C. To the residue obtained in the test for sulfated ash add 1 mL of hydrochloric acid and evaporate on a water-bath. Take up the residue in 20 mL of water. The solution gives reaction of sodium.

TESTS
pH: 5.0 to 7.0 for the suspension.
Shake 1 g with 100 mL of carbon dioxide-free water for 5 min.
Sodium chloride and sodium glycollate: Maximum 0.5 per cent (dried substance) for the sum of the percentage contents of sodium chloride and sodium glycollate.
Water: soluble substances: Maximum 10.0 per cent.
Loss on drying: Maximum 10.0 per cent, determined on 1.000 g by drying in an oven at 105C for 6 h.
Sulfated ash: 14.0 per cent to 28.0 per cent (dried substance), determined on 1.0 g.
Microbial contamination:
TAMC: acceptance criterion 1000 CFU/g.
TYMC: acceptance criterion 100 CFU/g.
Absence of Escherichia coli.
Settling volume: Place 75 mL of water in a 100 mL graduated cylinder and add 1.5 g of the substance to be examined in 0.5 g portions, shaking vigorously after each addition. Dilute to 100.0 mL with water and shake again until the substance is homogeneously distributed. Allow to stand for 4 h. The settling volume is between 10.0 mL and 30.0 mL.
Degree of substitution: 0.60 to 0.85 (dried substance).

Certifications :
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