we have gmp
lincomycin hydrochloride
characters |
white or almost white crystalline powder |
identification |
ir:consistent with that obtained with lincomycin hydrochloride reference standard |
|
the solution gives reaction(a) of chlorides |
specific optical rotation |
+135°~+150° |
appearance of solution |
clear and not more intensely coloured than reference solution y6 |
ph |
3.5~5.5 |
lincomycin b |
≤5.0% |
water |
3.1%~4.6% |
sulphated ash |
≤0.5% |
bacterial endotoxins |
<0.50 iu/mg |
heavy metals |
≤5ppm |
residual solvents |
1-butanol: ≤5000ppm |
|
1-octanol: ≤2ppm |
assay(anhydrous basis) |
89.5%~102.0% |