Product : Divalproex Sodium

Analysis As Per                

In- House Specification

Specification No.

FP – 011

Sr. No.

Test

Specification

1.       

Description

White or almost white crystalline powder.

2.       

Solubility

Soluble in ethanol (95 %), methanol, Isopropyl Alcohol; Partially soluble in water, ether.

3.       

Identification

The infra red absorption spectrum is concordant with the spectrum obtained from reference standard.

4.       

Loss on Drying

Not more than 2 %

5.       

Valproic Acid

Between 43 % to 47 % on dry basis

6.       

Sodium Valproate

Between 53 % to 57 % on dry basis

7.       

Sulphated Ash

Not more than 200 ppm

8.       

Related Substances

a)      Total Impurities not more than 0.3 %

b)      Individual impurities not more than 0.1 %

9.       

Assay

Between 98.5 % to 101 % on dry basis