Cross Carmelose Sodium
Application Specification            
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CROSCARMELLOSE SODIUM (Rapid Disintegrant) USP/NF
Sr. No. Parameters Specifications
01 Description White free flowing powder
02 Solubility Practically insoluble in Ether, and insoluble in other organic solvents.
03 Identification A, B, C Methylene Blue - Blue Fibrous Mass
1-Nepthol - Red - Purple colour at interface.
K - Antinate - Sodium Test Positive.
04 pH 5.0 to 7.0
05 Loss on Drying NMT 10.0%
06 Heavy Metals NMT 0.001%
07 Sodium Chloride & Sodium Glycollate NMT 0.5%
08 Degree of Subsitution 0.60 to 0.85
09 Contents of water soluble substance NMT 10.0 %
10 Organic Volatile Impurities Meets the requirement.
11 Residue on Ignition 14 to 28 %
12 Settling Volume 10 to 30 ml
MICROBIAL LIMITS
01 Total Aerobic Microbial Count N.M.T. 100 CFU/gm1
02 Total Yeast & Mould Count N.M.T.20 CFU/gm
03 Staphylococcus Aureus Absent
04 Escherichia Coli Absent
05 Pseudomonas Aeruginosa Absent
06 Salmonella Species Absent

STORAGE CONDITIONS:
Storage container tightly closed, under low moisture and heat conditions. Keep container in a cool and

well-ventilated area. Material should be store under room temperature

 
 
Design by : ACCURATE INFOCOM