SPECIFICATION

 

Product : Sodium Valproate BP

 

Analysis As Per

BP

Specification No.

FP-003

Sr. No.

Test

Specification

Characters

A white or almost white, crystalline powder, hygroscopic, very soluble in water, slightly to freely soluble in alcohol.

Identification

a)      Examine by infrared absorption spectrophotometry (2.2.24), comparing with the spectrum obtained with sodium valproate CRS. If the spectra obtained in the solid state for the substance to be examined and the reference substance show differences, record further spectra using discs prepared by placing 50 µl of a 100 g/l solution in methanol  R on a disc of potassium bromide R and evaporating the solvent in vacuo. Use the discs immediately.

b)      Examine the chromatograms obtained in the test for related substances. The retention time of the principal peak in the chromatogram obtained with test solution (b) corresponds to that of the principal peak in the chromatogram obtained with reference solution

c)      2 ml of solution S (see Tests) gives reaction (a) of sodium (2.3.1).

Aci