ITEMS

SPECIFICATION

RESULTS

Characters

A white crystalline powder

     Conform

Solubility

Very soluble in water,slightly soluble in ethanol (96%)

      Conform

Identification

Infrared Absorption

Conform

HPLC

Conform

Organic impurities

Lincomycin ≤1.0%

N.D

Clindamycin B ≤2.0%

0.8%

              7-epiclindamycin  ≤4.0%

0.4%

any other individual impurity ≤1.0%

N.D

 total related compounds ≤6.0%

1.4%

Crystallinity

Meets the requirement

Conform

pH

3.0~5.5 ,in a 100mg/ml solution

4.3

Water

3.0% ~6.0%

3.8%

Assay

Not less than 800μg of clindamycin(C₁₈H₃₃ClN₂O₅S)per mg

884μg/mg

Conclusion: Conforms to USP38 standard