Calcium CMC (Carboxy Methyl Cellulose - Calcium) JP

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Carboxymethylcellulose calcium is the calcium salt of carboxymethylcellulose and is used commonly as an FDA-approved disintegrant in pharmaceutical manufacturing. Disintegrants facilitate the breakup of a tablet in the intestinal tract after oral administration. Without a disintegrant, tablets may not dissolve appropriately and may effect the amount of active ingredient absorbed, thereby decreasing effectiveness. Calcium CMC helps tablets to disintegrate rapidly and also improves dissolution properties.

Tests	Specifications
Chemical Tests
Appearance	Carmellose Calcium as white to yellowish white powder, free from extraneous substance like black particle
Solubility	Practically insoluble in ethanol(95%) and in diethyl ether. It swells with water to form a suspension.
pH (1% in 100 ml CO2 free water)	Between 4.5 to 6.0
Identification Tests
Test - A	A red purple color develops
Test - B	A wit flocculent precipitate is produced
Test - C	A brown, flocculent precipitate is produced
Test - D	The solution responds to the Qualitative test for calcium salt
Alkalinity	No red color develops
Chlorides	Not more than 0.36% w/w
Sulphates	Not more than 1.0% w/w
Heavy Metals	Not more than 20 ppm
Loss on drying (at 105⁰ C for 4 hours in oven)	Not more than 10% w/w
Residue on Ignition (Calculated on dried basis)	10.0% to 20.0%
Residual Solvents (Methanol)	Not more than 3000 ppm
Physical Tests
Particle Size	Not less than 95% passing through 100 Mesh
Microbial Limits
Total Aerobic Microbial Count	Not more than 1000 CFU/G
Total Yeast and Mold Count	Not more than 100 CFU/G

Shelf life: 3 years
Storage: Keep the product tightly closed and dry