Hydrochlorothiazide

Contents

Specification

Results

Characteristics

White or almost white Crystalline powder

complies

Solubility

Very slightly soluble in water, slightly soluble in alcohol, Soluble in acetone and dilute solutions of alkalines hydroxides

complies

Coalition Band

266°Cto270°C,with decomposition

complies

Identification

Meets the requirements

complies

Acidity or alkalinity

≤0.4ml

0.2ml

Chloride

≤ 0.03%

< 0.01%

Selenium

< 0.003%

< 0.003%

Heavy metal

< 0.001%

< 0.001%

Residue on ignition

≤0.1%

0.03%

Related Substances

a)Any peak

b)Sum of peak

≤0.5%

≤1.0%

0.28%

0.35%

4-Amino-6-chloro-1.3-

-Benzenedisulfonamide

< 1%

0.39%

Loss on drying

≤ 0.5%

0.04%

Organic volatile impurities

Meets the requirements

Complies

Assay

98.0-102.0%(on the dried basis sub)

99.58 %

Conclusion: It complies with the requirements of the   USP32.

Packaging details:

25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.

Storage:

Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat

Shelf Life:

5 years if sealed and store away from direct sun light.