Lincomycin Hcl

CAS number: 859-18-7

Molecular formula: C18H35ClN2O6S

molecular weight: 442.9983

Chemical structure:

Name of Product:
Lincomycin hcl
Shelf Life:3 years
Specification:EP8.0
Test ItemsSpecificationResults of Analysis
Characters
A white or almost white crystalline poweder; solubility conformedAlmost white crystalline powder; Solubility Conformed
IdentificationA. The IR spectrum conforms to that obtained with the reference substanceA.The IR spectrum conforms to that obtained with the reference substance
B. Its solution gives reaction (a) of chloridesB.Its solution gives reaction (a) of chlorides
Appearance of solution
Clear and not more intensely coloured than reference solution Y6Clear and not more intensely coloured than reference solution Y6
PH3.5-5.54.3
Specific optical rotation135.0°-150.0°143°
Related substancesImpurity 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 5ppmNot more than 5ppm
Water3.1%-4.6%4%
Suphated ash≤0.5%0.1%
Particle size100% pass through 30mesh or 60mesh or 80mesh100% pass through 30mesh
Bacterial endotoxinsLess than 0.50IU/mgLess than 0.50IU/mg
Residual solventsn-Butanol:Not more than 5000ppm139ppm
Octanol:Not more than 2ppmundetected
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%