Bicortone

Items

Specifications

Results

Appearance

White to practically white crystalline powder

White crystalline powder

Identification

A: Infrared Absorption

Conforms to the IR spectrum of Prednisone RS

Conforms

B

Dissolve about 6mg in 2mL of sulfuric acid, and allow to stand for 5 minutes: an orange color is produced, Pour the solution into 10mL of water,  the color changes first to yellow and then, gradually, to blush green

Conforms

Specific rotation

+167°~+175°

+173°

Water

≤1.0%

0.25%

Residue on ignition

≤0.5%

Conforms

Chromatographic purity

Any individual impurity

≤1.5%

0.29%

Total impurities

≤2.0%

1.20%

Assay

97.0%~102.0% (on anhydrous basis)

100.8%

Conclusion

It Conforms to USP37