Description

A white to off white crystalline powder

Solubility

Freely soluble in dilute HCl Sparingly soluble in water

Identification

a)      By IR

     b)   By HPLC                             

By IR spectrum the infrared absorption spectrum of the test sample exhibits maxima only at the sample wavelength as that of the working standard.

Retention time of the principal peak in the chromatogram obtained with sample solution should match with that of the principal peak in chromatogram obtained with standard solution

Loss on drying (At 75°C for 3 hrs.)

NMT 0.50%

Melting Range

should between 180°C and 188°C

Optical  rotation

Should be between +10.0° and +12.0°

Residue on ignition

NMT 0.10%w/w

Heavy metals

NMT 20ppm

Mandalic acid  content

NMT 0.1%

Related substances(by HPLC)

a) Max. individual impurity     : NMT 0.50%

b) Total impurities                    : NMT 1.0%

Assay on anhydrous basis

(by HPLC)

between 98.0% and 101.0% w/w

Particle size

100% passes through 80 mesh