Vancomycin monohydrochloride Vancor
USP, BP, EP,CP
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Item |
Requirements |
Test Results |
Appearance |
A white or almost white powder |
An almost white powder |
Identification |
The retention time of the principal peak in the chromatogram obtained with test solution(a) is similar to the reference solution , comples |
Complies |
|
Reaction (a) of chlorides ,complies |
Complies |
Appearance of solution |
Clear |
Clear |
|
The absorbance of the solution at 450nm is not greater than 0.10 |
0.014 |
Water |
≤5.0% |
1.2% |
Ph |
2.5~4.5 |
2.5 |
Sulphated ash |
≤1.0% |
0.2% |
Chromatographic purity(HPLC) |
|
|
Vancomycin B |
≥ 93.0% |
95.4% |
Related substances: |
|
|
|
The content of no impurity is greater than 4.0% |
1.8% |
|
The sum of the contents of impurities is not greater than 7.0% |
4.6% |
Bacterial endotoxins |
≤ 0.25EU/mg |
Complies |
Sterility |
Sterility |
Sterility |
Heavy metals |
≤20ppm |
<20ppm |
Assay(microbial)(dried substance): |
≥1050IU/mg |
1072 IU /mg |
Conclusion |
Complies with Ph Eur 7.0 |
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
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