Items

Criteria

Characteristics

A white or almost white,crystalline powder

Identification

Infrared Absorption

Crystallinity

Meets the requirements

PH

Dissolve 0.2g in water and dilute to 20ml PH3.5-4.5

Residual Solvents

Acetone

Not more than 0.5%

Methanol

Not more than 0.3%

Ethanol

Not more than 0.5%

Pyriodine

Not more than 0.02%

Water

Not more than 6.0%

Bacterial endotoxins

Less than 0.58USP EU per mg/bf clindamycin

Assay

Anhydrous substance less than 758ug of clindamycin per mg