API

Lincomycin Hcl

Lincomycin Hcl Veterinary usage EP8.0 Standard

Item Standard Results
Appearance A white or almost white crystalline powder; Odorless or has a faint odor Conforms
Solubility Freely soluble in water and in dimethyformamide; very slightly soluble in acetone Conforms
Identification IR spectrum of sample conforms to that of reference standard Conforms
Specific optical rotation  +135~+150° +142°
Water 3.1%-6.0% 3.8%
pH 3.0-5.5 4.4
Related Substances  Impurity A0.5% 0.11%
Impurity B0.5% 0.12%
Impurity C0.20% 0.10%
Unidentified0.10% 0.03% 
Total Impurities2.0% 0.6%
Heavy metals 5ppm <5ppm
Bacterial endotoxins 0.50IU/mg 0.5IU/mg
Total aerobic microbial count 1000cfu/g Meets the requirement
Total combined yeasts and molds count 100cfu/g Meets the requirement
N-Butanol ≤0.5% No detected
Acetone ≤0.5% No detected
Lincomycin B  5.0% 2.6%
Assay (anhydrous substance)    Sum of the contents of Lincomycin Hydrochloride and Lincomycin B Hydrochloride: 96.0-102.0% 98.4%

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