product

Prednisolone Micronized

CAS NO: 50-24-8

Specification: BP/USP

Product Name Prednisolone Micronized
Quality Standard BP/USP/EP

 

Testing Items Critrion
Appearance White or off white crystalline powder
Identification A B Positive
Specific Optical rotation +96º to +102º
Related Substances EPI-Prednisolone≤0.5%
Hydrocortisone ≤0.5%
Prednisone ≤0.3%
Dehydro-RS≤0.3%
Any other impurity≤0.10%
Total Impurities ≤2.0%
Loss on drying ≤1.0%
Assay 97.0%-103.0%
Residual solvents Methaonl ≤700ppm
Acetone≤200ppm
Particle size distribution 98%≤30um
80%≤15um

 

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