Evaluation of Croscarmellose Sodium


Manufacturer Mingtai U.S. Brand
Trade name Disolcel® Brand X
Identification A Conform Conform
Identification B Conform Conform
Identification C Conform Conform
pH 6.25 6.54
Settling volume (ml) 18 21
Loss on drying % 6.2 1.6
Content of water soluble materials 5.2 3.2
Sodium Chloride & Sodium Glycolate 0.10 0.06
Heavy metal (ppm) Conform Conform
Degree of substitution 0.79 0.76
Particle size 200# (retained) < 1.0 < 1.0
Particle size 325# (retained) 6.8 4.0
Organic volatile impurities Conform Conform
Total aerobic microbial Conform Conform
Total molds and yeasts Conform Conform
Escherichia coli Absence Absence
Staphylococcus aureus Absence Absence
Salmonella species Absence Absence
Pseudomonas aeruginosa Absence Absence

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