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S.No Test Specification
1.

Description

A white to off white powder
2.

Solubility

IR absorption spectrum of sample should be concordant with standard
3.

Melting point range

Between 205°C and 211°C
4.

Sulphated Ash

Not more than 0.5% w/w
5. Loss on drying Not more than 2.0%w/w
6.

Chromatographic Purity by HPLC

Not less than 98.0%
7. Assay of Hydrochloric acid Between 11.0% and 15.0% on dried basis
8.
Assay by chemical
Not less than 98.0% w/w on dried basis