Lincomycin HCL CAS NO.21462-39-5

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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
Identification	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
Residual solvents	acetone Not more than 0.5%	0.05%	Conform
Assay ( on anhydrous basis)	Lincomycin B maximum 5.0%	2.7%
Assay ( on anhydrous basis)	Sum of the contents of lincomycin hydrochloride and lincomycin B hydrochloride: 96.0%－102.0%;	100.1%	Conform
Conclusion:meeting the requirement of the monograph of Lincomycin hydrochloride in Ph.Eur7.3. THIS PRODUCT DOES NOT INCLUDE ANY ANIMAL ORIGIN INGREDIENTS.