Chemical Name:?AC-DI-SOL (Croscarmellose Sodium NF)????RM Control No.:__________

PARAMETERS

USP

STANDARD

SAMPLE

REMARKS

Description

White, free-flowing powder

Solubility

Partially soluble in water Insoluble in alcohol, ether, and in other organic solvents

Identification

A: It absorbs the methylene blue and settles as a blue, fibrous mass

B: A reddish-violet colour develops at the interface

C: Responds to the flame test for Sodium < 191>

Microbial limits <61>

The total aerobic count does not exceed 1000 cfu per g, the total combined molds and yeasts count does not exceed 100 cfu per g, and meets the requirements of the test for absence of Escherichia coli

pH <791>

The pH of the dispersion is between 5.0 and 7.0

Loss on drying <731>

It loses not more than 10.0% of its weight

Sodium chloride and sodium glycolate <541>

The sum of the percentages of sodium chloride and sodium glycolate is not more than 0.5%

Residue on ignition <281>

Between 14.0% and 28.0% calculated on the dried basis

Heavy metals Method II <231>

Limit 0.001%

Degree of substitution

It is between 0.60 and 0.85 calculated on the dry basis

Content of water-soluble material

Not more than 10.0% is found

Setting volume

It is between 10.0 and 30.0 ml

Organic volatile impurities?Method IV <467>

Meets the requirements