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Product Name: Lincomycin HCL

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CAS No: 17017-22-0

Melecular Formula: C 33H50Cl3N5O8S

Molecular Weight: 783.2028


Chemical Structure:


CERTIFICATE OF ANALYSIS

Product Name

Lincomycin Hydrochloride

Reference

EP8.0

Shelf Life

3 years

Testing Item

Specification

Results

Characteristics

White or almost white crystalline powder

White crystalline powder

Identification A IR B Chloride

Conform to requirements

pass

Positive

pass

Appearance of solution

Clear and not more intenselyConform than Y6

pass

Specific optical rotation

+135℃ ~+150℃

+142℃

solubility

Conform to requirements

pass

pH

3.5~5.5

4.3

Water by KF

3.1%~4.6%

3.8%

Sulphated Ash

≤0.5%

0.08%

Heavy Metals

≤5ppm

undefined5ppm

Related Substances
Impurity A
Sum of peaks due to Impurity B
Impurity C
Any of other Impurity
Total Impurities

 

≤0.5%
≤0.5%
≤0.2%
≤0.1%
≤2.0%   

 

0.32%
0.22%
Not detected
0.08%
0.68%

Bacterial Endotoxins

undefined0.50IU/mg

undefined0.50IU/mg

Residual Solvent by GC
Acetone
Butanol
2-octanol

 

≤500ppm
≤1000 ppm
≤500ppm

 

59ppm
320 ppm
Not detected

Assay(anhydrous substance)
Lincomycin Hydrochloride
+Lincomycin B Hydrochloride
Lincomycin B Hydrochloride

 

96.0~102.0%

≤5.0%

 

99.2%

2.6%

Conclusion: Conforms with EP8.0

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