Tests Item

Standard

Appearance

A pale yellow powder almost odorless

Identification

UV,IR

Clarity of solution

5.0%W/V solution in DMF is clear

Heavy metal

NMT 10ppm

Loss on drying

NMT 0.5%

Sulphated Ash

NMT 0.1%

Granulometric of powder

100-120 mesh

Related substance

Ethy1,4-hydroxy-2-benzothinzine-3-carboxylate-1,1-dioxide NMT 0.1%

5-methylthiazol-2ylamine   NMT 0.1%

4-hydroxy-2methy1-N-(5-methy1-1,3-thiazol-2-yl)-2H-1.2-benzonthiazine-3-carboxamide,1-dioxide      NMT0.05%

Other individual impurity  NMT 0.1%

Total impurities  NMT 0.3%

Assay (HPLC)

99.0% to 100.5%(on the anhydrous basis)

Microbiological purity

Comply to the test