General Information Azithromycin IP/BP/USP
| CAS Number | Molecular Formula | Molecular Weight |
|---|---|---|
| 83905-01-5 | C38H72N2O12 | 785.0 |
Specification and results for Azithromycin IP/BP
| Sr. No. | Test Parameter | Specification Required | Results |
|---|---|---|---|
| 1 | Description | A white or almost white powder | White Powder |
| 2 | Identification | Complies with A: infrared absorption | Complies |
| B: Corresponds to Standard | Complies | ||
| 3 | Appearance of solution | clear and colorless Ref. By IP | Complies |
| 4 | pH | 9pH to 11pH | 10.15pH |
| 5 | Specific optical rotation | -45.0° to -49.0° | -47.7 ° |
| 6 | Heavy Metals | 25ppm | Complies |
| 7 | Sulphated ash | <0.2% | 0.03% |
| 8 | Water | 1.8% to 6.5% | 4.25% |
| 9 | Assay By HPLC | 96% to 102% | 99.27% |
Related substances
| Sr. No. | Test Parameter | Specification Required | Results |
|---|---|---|---|
| 1 | Impurity B (3-Deoxyazithromycin) | ≤2.0% | 0.37% |
| 2 | Impurity L (Azithromycin 3'-N-Oxide) | ≤0.5% | Not Detect |
| 3 | Impurity M (3′-(N, N-Didemethyl)-3′-Nformylazithromycin) | ≤0.5% | Not Detect |
| 4 | Impurity E (Amino Azithromycin) | ≤0.5% | 0.04% |
| 5 | Impurity F (3′-N-Demethyl-3′-N-formylazithromycin) | ≤0.5% | 0.03% |
| 6 | Impurity D (14-Demethyl-14-(hydroxymethyl) azithromycin) + Impurity J (13-ODecladinosylazithromycin) | ≤0.5% | Not Detect |
| 7 | Impurity I (N'-Desmethyl Azithromycin) | ≤0.5% | 0.04% |
| 8 | Impurity C (3″-O-Demethyl Azithromycin) | ≤0.5% | 0.05% |
| 9 | Impurity N (3′-De(Dimethylamino)-3′- oxoazithromycin) | ≤0.5% | 0.07% |
| 10 | Impurity H (3′-N-[[4-(Acetylamino) phenyl] sulfonyl]- 3′-N-demethylazithromycin) | ≤0.5% | Not Detect |
| 11 | Impurity A (N6-Demethylazithromycin) | ≤0.5% | Not Detect |
| 12 | Impurity P (Unknown) | ≤0.5% | 0.05% |
| 13 | Impurity O (2-Desethyl-2-propylazithromycin) | ≤0.5% | 0.06% |
| 14 | Impurity G(3′-N-Demethyl-3′-N-[(4-methylphenyl) sulfonyl] azithromycin) | ≤0.2% | Not Detect |
| 15 | Any other impurity | ≤0.2% | 0.1% |
Specification and results for Azithromycin USP
| Sr. No. | Test Parameter | Specification Required | Results | |
|---|---|---|---|---|
| 1 | Description | A white or almost white powder | White Powder | |
| 2 | Identification | Complies as per IR test, Ref. USP | Complies | |
| 3 | Crystallinity | Meets the requirements | Complies | |
| 4 | pH | 9 to 11 | 10.15 | |
| 5 | Specific optical rotation | -45.0° to -49.0° | -47.7 ° | |
| 6 | Heavy Metals | <25ppm | Complies | |
| 7 | Water Determination | 4% to 6.5% | anhydrous: NMT 2.0% | 4.25% |
| dihydrate: 4.0%–5.0% | ||||
| monohydrate: 1.8%–4.0% | ||||
| 8 | Assay By HPLC | 945–1030 μg/mg on the anhydrous basis | 997 μg/mg | |
| 9 | Bulk density (Tapped) | 0.5 g/ml to 0.7 g/ml | 0.59 g/ml | |
| 10 | Residue on Ignition | NMT 0.3%, | 0.067% | |
Organic Impurities(Ref.-USP)
| Sr. No. | Test Parameter | Specification Required | Results |
|---|---|---|---|
| 1 | Azithromycin N-oxide | ≤0.5% | Complies |
| 2 | 3′-(N,N-Didemethyl)-3′-N-formylazithromycin | ≤0.5% | Complies |
| 3 | Erythromycin A iminoether | ≤0.5% | Complies |
| 4 | 3′-(N,N-Didemethyl)azithromycin(aminoazithromycin) | ≤0.5% | Complies |
| 5 | Azithromycin related compound Fc | ≤0.5% | Complies |
| 6 | Desosaminylazithromycin | ≤0.3% | Complies |
| 7 | 3′-N-{[4-(Acetylamino)phenyl]sulfonyl}-3′,3′-didemethylazithromycin | ≤0.15% | Complies |
| 8 | N-Demethylazithromycin | ≤0.7% | Complies |
| 9 | Erythromycin A oxime | ≤0.5% | Complies |
| 10 | Azithromycin C (3″-O-demethylazithromycin) | ≤0.5% | Complies |
| 11 | 3′-De(dimethylamino)-3′-oxoazithromycin | ≤0.5% | Complies |
| 12 | 3′-N-{[4-(Acetylamino)phenyl]sulfonyl}-3′-demethylazithromycin | ≤0.5% | Complies |
| 13 | Azaerythromycin A | ≤0.5% | Complies |
| 14 | Azithromycin impurity P | ≤0.2% | Complies |
| 15 | 2-Desethyl-2-propylazithromycin | ≤0.5% | Complies |
| 16 | 3′-N-Demethyl-3′-N-[(4-methylphenyl)sulfonyl]azithromycin | ≤0.5% | Complies |
| 17 | 3-Deoxyazithromycin (azithromycin B) | ≤1.0% | Complies |
| 18 | Any other unidentified impurity | ≤0.2% | Complies |