Prednisolone Acetate IP

Specification Prednisolone Acetate

Sr. No. Test Specification
1 Description A white or almost white, crystalline powder.
2 Solubility Slightly soluble in ethanol (95 percent) and in Dichloromethane , practically insoluble in water.
3 Identification By IR : The Infra-red absorption spectrum of sample is concordant with that of the standard.
4 Specific optical rotation Between +128°C to + 137°C (dried substance)
5 Loss on Drying NMT 0.5 %
6 Related Substances Impurity – A : NMT 1.0%
Impurity – B : NMT 1.0%
Impurity – C : NMT 1.0%
Single Impurity –: NMT 0.1 %
Total Impurity – : NMT 2.0%
7 Assay by UV NLT 97.0% and NMT 103.0% of C23H30O6 (on dried Basis)