Product Name: Ranitidine Hydrochloride

Basis:   USP Standard

ITEMS

STANDARD

RESULTS

DESCRIPTION

White to pale yellow,crystalline,practically odorless powder

Almost white crystalline

Practically odorless powder

IDENTIFICATION

A: the IR absorption spectrum of the test specimen comply with that of the corresponding USP Reference Standard.

B: Absorptivities at 229nm and 315nm, do not differ by more than 3.0%.

C: A solution of it meets the requirements of the tests for Chloride.

It complies with that of the corresponding USP Reference Standard

Less than 3.0%

It meets the requirements of the tests for Chloride

pH

4.5~6.0

5.6

Loss on drying

Not more than 0.75%

0.10%

Residue on ignition

Not more than 0.1%

0.06%

Chromatographic purity

Ranitidine Related Compound B not more than 0.5%

Less than 0.5%

Any other impurity not more than 0.3%

Less than 0.3%

the sum of all impurities not more than 1.0%

Less than 1.0%

Organic volatile impurities

Meets the requirements

Meets the requirements

Residual solvents

Meets the requirements

Meets the requirements

ASSAY (dried basis)

(Content of C13H22N4O3S·HCl)

97.5%~102.0%

99.3%

Conclusion

It complies with USP Standard.