China High Purity Azithromycin Raw Material 83905-01-5 Bulk Azithromycine, Find details about China Azithromycin Powder, Azithromycin USP from High Purity Azithromycin Raw Material 83905-01-5 Bulk Azithromycine
Product name | Azithromycin |
Other name | 9-Deoxo-9a-methyl-9a-aza-homoerythromycin A |
Specification | 99% |
Appearance | White or off white crystalline powder |
CAS | 83905-01-5 |
MF | C38H72N2O12 |
MW | 748.98 |
Items | Specifications | Results |
Appearance | White or almost white crystalline powder | White crystalline powder |
Solubility | Practically insoluble in water, freely soluble in anhydrous ethanol and in methylene chloride | Conforms |
Idetification | 1) IR: Conforms to the spectrum of Azithromycin RS | Conforms |
2) HPLC: The retention time of azithromycin peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the Standard preparation, as ovtained in the assay | ||
Specific rotation | -45°~ -49° | -47° |
Crystallinity | Meets the requirements | Conforms |
pH | 9.0~11.0 (2mg/ml methanol-water(1:1)) | 10.1 |
Water | 4.0%~5.0% | 4.60% |
Residue on ignition | ≤0.3% | 0.01% |
Heavy metals | ≤25ppm | <25ppm |
Impurity A ≤0.5% | Not detected | |
Impurity B ≤1.0% | 0.40% | |
Impurity C ≤0.5% | 0.22% | |
Impurity J ≤0.3% | 0.11% | |
Impurity E ≤0.5% | Not detected | |
Impurity F ≤0.5% | <0.10% | |
Impurity G ≤0.5% | Not detected | |
Related Substances(HPLC Test 2) | Impurity I ≤0.7% | Not detected |
Impurity L≤0.5% | Not detected | |
Impurity M≤0.5% | Not detected | |
Impurity N ≤0.5% | Not detected | |
Impurity O≤0.5% | 0.11% | |
Impurity P ≤0.2% | <0.10% | |
Any other impuirty ≤0.2% | <0.10% | |
Total impurities ≤3.0% | 0.84% | |
Residual Solvents | Methylene Chlorde≤600ppm | Not detected |
Acetone ≤5000ppm | 330ppm | |
Assay | 945~1030μg/mg (Anhydrous substance ) | 978μg/mg |
Conclusion | The results can conforms with the USP37 standard. |
1. Azithromycin is used to treat or prevent certain bacterial infections, most often those causing middle ear i nfections, strep throat, pneumonia, typhoid, and sinusitis;
2. It has been used primarily to prevent bacterial infections in infants and those with weaker immune system
Xi'an Wucine Bio Industries Inc is a national key high-tech enterprise,which mainly specializes
in the R&D,operation and production of pharmaceuticals,and intermediates.Our company is
situated in E&T development zone,xi'an city shaanxi,it is easy of access.Our company has
independent R&D center,raw material synthesis workshop,has advanced quality instruments
and equipmentm,several product patents there are 15 experts in our research team.We insist
in innovation and produce high quality products.