Product Brief Introduction
Product name: Vancomycin Hydrochloride
CAS：1404-93-9
MF: C66H76Cl3N9O24
MW: 1485.714
Product Specification
|
Item |
Specification |
|
|
Appearance |
White, almost white , or tan to brown free-flowing powder |
|
|
Identification |
IR: The infrared absorption spectrum of the sample complies with the reference standard. |
|
|
|
Chloride: Meets the requirements |
|
|
Solubility |
Freely soluble in water, insoluble in ether and chloroform |
|
|
PH |
2.4~4.5 |
|
|
Moisture |
≤ 5.0% |
|
|
Residue on Ignition |
≤ 1.0% |
|
|
Related Substances
|
Impurity A ≤ 3.0% |
|
|
Impurity B+E ≤ 2.0% |
||
|
Impurity C ≤ 1.0% |
||
|
Impurity D ≤ 1.5% |
||
|
Impurity F ≤ 1.5% |
||
|
Impurity G ≤ 1.2% |
||
|
Impurity H ≤ 3.0% |
||
|
Impurity I ≤ 1.2% |
||
|
Impurity J ≤ 1.6% |
||
|
Impurity K ≤ 1.2% |
||
|
Impurity M ≤ 1.5% |
||
|
Unspecified impurity before elution of vancomycin B |
Each impurity≤ 0.8% |
|
|
Impurity exceed 0.3% ≤ 5 |
||
|
Unspecified impurity after elution of vancomycin B |
Each impurity≤ 0.8% |
|
|
Impurity exceed 0.3% ≤ 3 |
||
|
Total impurities ≤ 9.0% |
||
|
Bacterial Endotoxins |
≤ 0.33 EU/mg |
|
|
Total Plate Count |
≤ 100cfu/g |
|
|
Yeasts&Molds |
≤ 10cfu/g |
|
|
Vancomycin B |
≥ 91.0% |
|
|
Assay (on dried basis) |
≥ 900μg/mg |
|
