Item

Specification

Test Results

Characteristics

A white crystalline powder

White crystalline powder

Identification

A: IR the same as the reference standard

Complies

B:The principal spot obtained from the test solution corresponds to that the reference solution.

Complies

Specific rotation

-33.5°~ -37.0°(w/w)

-35.3°

pH

4.0~6.5

5.3

Loss on drying

≤0.5%(w/w)

0.04%

Residue on ignition

≤0.25%(w/w)

0.03%

Heavy metals

≤0.001%(w/w)

<0.001%

Residue solvent

Methanol

≤3000ppm

<25ppm

Ethanol

≤5000ppm

110ppm

Chromatographic purity

Individual peak

≤0.25%(Area normalization)

0.12%

Total peaks

≤1.0%(Area normalization)

0.1%

Assay(HPLC)

98.9-101.5%(w/w)

100.2%

Conclusion: This batch meets the specification of USP 35