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Vancomycin is an antibiotic used to treat a number of bacterial infections. It is recommended intravenously as a first-line treatment for complicated skin infections, bloodstream infections, endocarditis, bone and joint infections, and meningitis caused by methicillin-resistant S. aureus. Blood levels may be measured to determine the correct dose. Vancomycin is also recommended by mouth as a treatment for severe Clostridium difficile colitis. When taken by mouth it is very poorly absorbed.
Common side effects include pain in the area of injection and allergic reactions. Occasionally, hearing loss, low blood pressure, or bone marrow suppression occur. Safety in pregnancy is not clear, but no evidence of harm has been found, and it is likely safe for use when breastfeeding.It is a type of glycopeptide antibiotic and works by blocking the construction of a cell wall.
Specification:
|
Test |
Specification |
Results |
|
|
Characteristics |
A white or almost white powder |
Conform |
|
|
Identification |
Infrared absorption |
Conform |
|
|
Chromatographic purity |
Vancomycin B |
≥88.0% |
93.9% |
|
Any peak other than the main peak |
≤4.0% |
1.0% |
|
|
monodechlorovancomycin |
≤4.7% |
1.5% |
|
|
Water |
≤5.0%(W.F.) |
2.4% |
|
|
Bacterial endotoxins |
<0.25EU/mg |
<0.25EU/mg |
|
|
Potency(dried substance) |
≤925ug/mg |
1120ug/mg |
|
|
Particulate matter |
Conform |
Conform |
|
|
Heavy metals |
≤0.003% |
<0.003% |
|
|
Sterility |
Conform |
Conform |
|
|
Clarity |
Conform |
Conform |
|
|
Residual solvents |
Ethanol≤5000ppm |
63ppm |
|
|
Conclusion |
The specification conform to USP35 |
||
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
