Azithromycin
Inquiry
| Post Date: | Jan 28,2013 |
| Expiry Date: | Jul 27,2013 |
| Detailed Description: |
Cas No. :83905-01-5
spec.
Tests Acceptance Criteria Results Characters white or almost white crystalline powder, no order and bitter. Practically insoluble in water, freely soluble in anhydrous ethanol and in methylene chloride Conforms Identification (1) IR: Conforms to the Azithromycin RS spectrum (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 obtained in the Assay Conforms Specific rotation -45°~-49°(Anhydrous subatance 20mg/ml dehydrated alcohol) -47° Crystallinity Meets the requirement Conforms PH 9.0~11.0(2mg/ml methanol-water(1:1)) 10.1 Water 4.0%~5.0% 4.3% Residue on Ignition ≤0.3% 0.02% Heavy metals ≤0.0025% less 0.0025% Related substances (HPLC) (1) desosaminylazithromycin ≤0.3% 0.02% N-demethylazithromycin ≤0.7% 0.44% (2) Any other impurity ≤1.0% 0.84% (3) Total impurity ≤3.0% 1.6% Residual solvents Methylene Clloride ≤600ppm Not detected Acetone ≤5000ppm 1306.5ppm Assay(HPLC) 945~1030μg/mg (Anhydrous substance) 966μg/mg Conclusion Conforms to USP32 specification for Azithromycin |
| CAS Registry Number: | 83905-01-5 |
| Synonyms: | ;Azithromycine;11-(4-dimethylamino-3-hydroxy-6-methyl-oxan-2-yl)oxy-2-ethyl-3,4,10-tr;1-Oxa-6-azacyclopentadecan-15-one,13-((2,6-dideoxy-3-C-methyl-1-3-O-methyl-alpha-L-ribo-hexopyranosyl)-oxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-((3,4,6-trideoxy-3-(dimethylamino)-beta-D-xylo-hexopyranosyl)oxy);9-deoxo-9a-methyl-9a-aza-homoerythromycin A;9-Deoxo-9-methyl-9a-aza-9-homoerythromycin A;N-methyl-11-aza-10-deoxo-10-dihydroerythromycin A;Sumamed;(2R,3S,4R,5S,6R,8R,11S,12R,13R,14S)-5-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyl-tetrahydropyran-2-yl]oxy-14-ethyl-6,12,13-trihydroxy-3-[(2S,4R,5S,6R)-5-hydroxy-4-methoxy-4,6-dimethyl-tetrahydropyran-2-yl]oxy-2,4,6,8,10,11,13-heptamethyl-15-oxa-10-azacyclopentadecan-1-one; |
| Molecular Formula: | C38H72N2O12 |
| Molecular Weight: | 748.9845 |
| Molecular Structure: | 
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| Company: | Shijiazhuang Ruiersu Import and Export Company [ China ] |
| Contact: | lisa |
| Tel: | 0086-311-89643425 |
| Fax: | 0086-311-67908918 |
| Email: | lisawang.2011@hotmail.com |
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