Lincomycin HCL

Test items

Acceptance criteria

Result

Conclusion

Characters

A white or almost white crystalline powder

White crystalline powder

Conform

Identification

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

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

Conform

Its solution gives reaction(a) of chlorides

Its solution gives reaction(a) of chlorides

Conform

Appearance of solution

Clear and not more intensely coloured than reference solution Y₆

Clear and not more intensely coloured than reference solution Y₆

Conform

pH

3.5～5.5

4.9

Conform

Specific optical rotation

+135^º～+150^º

+141^º

Conform

Related substances

Impurity A  ≤0.5%

0.3%

Conform

Impurity B  ≤0.5%

0.2%

Impurity C  ≤0.2%

0.03%

Any unspecified impurity≤0.10%

0.02%

Total impurities:≤2.0%

0.2%

Heavy metals

Not more than 5ppm

Less than 5ppm

Conform

Water

3.1%～4.6%

3.9%

Conform

Sulfated ash

Not more than 0.5%

0.2%

Conform

Bacterial endotoxins

Less than 0.50 IU/mg

Less than 0.50 IU/mg

Conform

Residual solvents

n-Butanol: Not more than 5000ppm

Undetected

Conform

acetone Not more than 0.5%

0.05%

Assay ( on anhydrous basis)

Lincomycin B maximum 5.0%

2.7%

Sum of the contents of lincomycin hydrochloride and lincomycin B hydrochloride:

96.0%－102.0%;

100.1%

Conform