- Min.Order :1 Kilogram
- Purity: 99.9%
- Payment Terms : L/C,D/A,D/P,T/T,
Keywords
Azithromycin Arzomicin 83905-01-5
Quick Details
- Appearance:white or almost white crystalline powder
- Application:Pharmaceutical intermediates
- PackAge:Sealed container or at customer request
- ProductionCapacity:10|Metric Ton|Month
- Storage:Sealed container
- Transportation:Sealed container at cool dry place, keep away from light
Superiority:
1. Advanced Factory Building and Equipment
2. Competent technical team
3 .Strong R & D support
4,high quality products with high stability
5, Competitive price
5.Customer tailored service
Details:
|
ests |
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 |
||
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