Product : Progesterone BP

Analysis As Per

BP

Specification No.

FP-020

Sr. No.

Test

Specification

1.              

Description

White or almost white, crystalline powder or colourless crystals

2.              

Solubility

Practically insoluble in water, freely soluble in ethanol, sparingly soluble in acetone and in fatty oils.

3.              

Identification

a)      The infrared absorption spectrum is concordant with the reference spectrum of Levonorgestrel or with the spectrum obtained from Levonorgestrel RS.

b)      TLC.

4.              

Specific Optical Rotation

+186° to +194°

5.              

Related Substances

(By Liquid Chromatography)

Any single impurity: not more than 0.5 %

Total impurity not more than 0.8

6.              

Loss on Drying

Not more than 0.5 %

7.              

Assay

(By UV)

97.0 % to 103 % calculated on dry basis