Azithromycin Azithromycin dihydrate Azithromycin compact
1. GMP AVALIABLE ;
2. IN STOCK
3. FAST REPLY
QUALIFED ; EFFICIENCY; RESPONSIBLE
HangZhou Clake Biotech CO.,LTD is located in hangzhou city ,zhejiang province,China. We are engaged in export of APIs ,excipients,food additives and finished products. With more than 10years experience ,we established cooperated relationship with factorys.
Tests |
Specification |
Results |
||
Characters |
Appearance |
White or almost white powder |
White powder |
|
Solubility |
Practically insoluble in water ,freely soluble in anhydrous ethanol and in methylene chloride |
Conforms |
||
Identification |
IR: Conforms to the spectrum of Azithromycin R.S 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° |
-48° |
||
Crystallinity |
Meets the requirements |
Conforms |
||
pH |
9.0 ~ 11.0 (2mg/ml methanol-water [1:1]) |
9.8 |
||
Water |
4.0% ~ 5.0% |
4.6% |
||
Residue on ignition |
≤0.3% |
<0.01% |
||
Heavy Metals |
≤25ppm |
<25ppm |
||
Related substance (HPLC Test 2) |
Impurity A |
≤0.5% |
<0.10% |
|
Impurity B |
≤1.0% |
0.51% |
||
Impurity C |
≤0.5% |
0.23% |
||
Impurity J |
≤0.3% |
0.14% |
||
Impurity E |
≤0.5% |
Not detected |
||
Impurity F |
≤0.5% |
<0.10% |
||
Impurity G |
≤0.5% |
<0.10% |
||
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% |
<0.10% |
||
Impurity P |
≤0.2% |
<0.10% |
||
Total impurities |
≤3.0% |
0.88% |
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