Lincomycin Hcl

Shelf Life:

3 years

Specification:

EP8.0

Test Items

Specification

Results of Analysis

Characters

A white or almost white crystalline poweder; solubility conformed

Almost white crystalline powder; Solubility Conformed

Identification

A. The IR spectrum conforms to that obtained with the reference substance

A.The IR spectrum conforms to that obtained with the reference substance

B. Its solution gives reaction (a) of chlorides

B.Its solution gives reaction (a) of chlorides

Appearance of solution

Clear and not more intensely coloured than reference solution Y6

Clear and not more intensely coloured than reference solution Y6

PH

3.5-5.5

4.3

Specific optical rotation

135.0°-150.0°

143°

Related substances

Impurity A≤0.5%

0.3%

Impurity B≤0.5%

0.2%

Impurity C≤0.2%

0.1%

Any unspecified impurity≤0.10%

0.08

Total impurities≤0.2%

0.7

Heavy metals

Not more than 5ppm

Not more than 5ppm

Water

3.1%-4.6%

4%

Suphated ash

≤0.5%

0.1%

Particle size

100% pass through 30mesh or 60mesh or 80mesh

100% pass through 30mesh

Bacterial endotoxins

Less than 0.50IU/mg

Less than 0.50IU/mg

Residual solvents

n-Butanol:Not more than 5000ppm

139ppm

Octanol:Not more than 2ppm

undetected

Assay (anhydrous basis)

Sum of the contents of lincomycin hydrochloride and lincomycin B   hydrochloride: 96.0%-102.0%

100.7%

Lincomycin B hydrochloride: Not more than 5.0%

3.2%