| CAS No.: | 9004-34-6 |
| Molecular Weight: | yy g/mol |
| Chemical Formula | (C6H10O5)n |
Microcrystalline cellulose and Calcium carbonate compositions useful as pharmaceutical excipients as direct compression. The combination formula is better suited than the individual excipients, Microcrystalline cellulose, and Calcium carbonate. Improved disintegration properties were obtained by blending microcrystalline cellulose with an insoluble vehicle such as calcium carbonate.
Typical Compositions and Specifications of Microcrystalline cellulose + Calcium Carbonate:
Appearance: It occurs as white, free flowing, odorless powder
Identification:
A. Sift 20 g of sample for 5 min on an air-jet sieve equipped with a screen having 38-_m openings. If more than 5% is retained on the screen, mix 30 g of sample with 270 mL of water; otherwise, mix 45 g of sample with 255 mL of water. Mix for 5 min in a single-speed, high-speed (equal to or greater than 18,000 rpm) power blender (use a Waring Blender, Model 700G, or equivalent) that has a clover-shaped jar design. The jar and blades meet the following specifications: The jar has a 7.0-cm id at the bottom and a 9.2-cm id at the top and an overall height of 21.9 cm, and the four blades are arranged so that two of the blades are pointed up and two are pointed down. Transfer 100 mL of the dispersion into a 100-mL graduated cylinder and allow it to stand for 3 h. A white, opaque, bubble-free dispersion that does not form a supernatant liquid at the surface is obtained.
B. Add a few drops of iodine TS to 20 mL of the dispersion obtained in Identification Test A, and mix. No purple to blue or blue color appears.
Test B: Dissolve about 20 mg of the substance to be examined or the prescribed quantity in 5 mL of acetic acid R. Add 0.5 mL of potassium ferrocyanide solution R. The solution remains clear. Add about 50 mg of ammonium chloride R. A white, crystalline precipitate is formed.
Test B: Dissolve about 20 mg of the substance to be examined or the prescribed quantity in 5 mL of acetic acid R. Add 0.5 mL of potassium ferrocyanide solution R. The solution remains clear. Add about 50 mg of ammonium chloride R. A white, crystalline precipitate is formed.
Solubility: Insoluble in water.
pH (5% Solution): Between 8.0 to 11.0
Heavy metals: Not more than 10 ppm.
Loss on drying at 105C for 3h: Not more than 5.0%
Particle size: Not more than 1 % retained on 60 mesh screen (250µm).
Not less than 25 % retained on 200 mesh screen (75µm).
Microcrystalline cellulose: Not less than 62.0% and not more than 68.0% calculated on dried basis.
Calcium Carbonate: Not less than 32.0% and not more than 38.0% calculated on dried basis.
