TEST

SPECIFICATION

Description

A yellow coloured, round shaped biconvex, film coated tablet plain on both sides.

Identification:

A. IR

B. TLC

C. Colour Development

The IR spectrum of the test residue should be concordant with the reference spectrum of Methyldopa

The principal spot in the chromatogram obtained with test solution should correspond with the reference solution

Green colour should be produced when reacted with Ferric Chloride & HCl. On further reacted with ammonia purple colour should be produced & red colour should be produced when reacted with NaOH

Uniformity of weight

± 5%  of average weight

Average Weight

530.40 mg ± 5%

Weight of 20 Tablets

10.608 g ± 3%

Thickness

4.40 mm (± 0.2 mm)

Diameter

12.80 mm (± 0.2 mm)

Optical Rotation

-0.98° to -1.09°

Disintegration time

NMT 30 minutes in water medium at 37???

Dissolution

NLT 80% (Q) of LA

Assay of Methyldopa

95.0% to 105.0% of LA

(237.5 mg to 262.5 mg)