Product : Valproic Acid USP

Analysis As Per

USP

Specification No.

FP-002

Sr. No.

Test

Specification

Description

Colourless to pale yellow, slightly viscous, clear liquid having a characteristic odour.

Solubility

Slightly soluble in water; freely soluble in acetone, in methanol, in alcohol, in chloroform, in benzene, in ether; miscible with dichloromethane; Dissolves in dilute solutions of alkali hydroxides

Identification

a)      The infra red absorption spectrum is concordant with the reference spectrum of Valproic Acid

b)      The retention time of the principal peak in the chromatogram obtained with test solution corresponds to that of the principal peak in the chromatogram obtained with the reference solution.

Water

Not more than 1.0 %

Residue On Ignition

Not more than 0.1 %

Heavy Metals

Not more than 0.002%

Chromatographic Purity

a) Individual impurity not more than 0.1 %

b) Total impurities not more than 0.3 %

Organic Volatile Impurities

Meets the requirement as per USP

Assay

Between 98.0 to 102.0 % calculated on dry basis