| Powder: | Yes |
|---|---|
| Customized: | Customized |
| Certification: | GMP, ISO 9001, USP, BP |
| Suitable for: | Elderly, Children, Adult |
| State: | Powder |
| Purity: | >99% |
| Samples: |
|---|
| Customization: |
|---|
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| Production Name | Azithromycin |
| Test Method | HPLC |
| Purity | ≥98% |
| CAS No. | 83905-01-5 |
| Mol. Formula | C38H72N2O12 |
| Mol. Weight | 748.98 |
| Loss on drying | ≤2.0% |
| Water | 4.0%~5.0% |
| Residue on ignition | ≤0.3% |
| Heavy metals | ≤0.0025% |
| Package | 25kg/drum |
| Storage | In cool ,dry and clean |
Azithromycin is used for acute throat and tonsillitis which are caused by streptococcus pyogenes, otitis.
Azithromycin can treatment of media sinusitis acute bronchitis skin soft tissue infection which are caused by sensitive bacteria.
in Dihydrate is used for acute pharyngitis, acute tonsillitis caused by Streptococcus pyogenes.
Azithromycin is also used for pneumonia urethritis cervicitis and so on.
|
Test Item |
Analysis Specification |
Result |
|
Description |
White or almost white crystalline powder, No odor and bitter. |
Conforms |
|
Identification |
A: IR: Conforms to the Azithromycin RS spectrum B: HPLC: The retention time of azithromycin peak in the as obtained in the Assay. |
Conforms
Conforms |
|
Specific rotation |
-45°~-49°(Anhydrous substance 20mg/ml dehydrated alcohol) |
-47° |
|
Crystallinity |
Meets the requirements |
Conforms |
|
pH |
9.0~11.0 ( 0.1g /50ml methanol-water (1:1)) |
10.0 |
|
Water |
4.0%~5.0% |
4.4% |
|
Residue on Ignition |
≤0.3% |
0.02% |
|
Heavy metals |
≤0.0025% |
<0.0025% |
|
Residual solvents |
Methylene Chloride≤600ppm Acetone≤5000ppm |
Not detected 1159.0ppm |
|
Assay((HPLC) |
945~1030 μg /mg ( Anhydrous substance) |
965μg /mg |
|
Conclusion |
Conform to USP 26 Standard |
|
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