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Product name | AZITHROMYCIN | ||
CAS | 83905-01-5 | ||
HS CODE | 29419090 | ||
Expiry | 5years | ||
Standard | Current EP | ||
Appearance | White or almost white crystalline powder | ||
Solubility | Practically insoluble in water, freely soluble in anhydrous ethanol and inmethylene chloride | ||
Identification IR | Conforms to Azithromycin RSShould be clear and colourless .Between 9.0 and l1.0Between -45 and -49 | ||
Related substance | Impurity L | ≤0.5% | |
Impurity M | ≤0.5% | ||
Impurity E | ≤0.5% | ||
Impurity F | ≤0.5% | ||
Impurity D and J | ≤0.5% | ||
Impurity I | ≤0.5% | ||
Impurity C | ≤0.5% | ||
Impurity N | ≤0.5% | ||
Impurity H | ≤0.5% | ||
Impurity A | ≤0.5% | ||
Impurity P | ≤0.5% | ||
Impurity O | ≤0.5% | ||
Impurity G | ≤0.2% | ||
Impurity B | ≤2.0% | ||
Any other impurity | ≤0.2% | ||
Total impurities | ≤3.0% | ||
Heavy metals | ≤25ppm | ||
Water | 1.8%-6.8% | ||
Sulfated ash | ≤0.2% | ||
Assay On the anhydrous basis | 98.3% | ||
Residual solvents | Acetone | ≤3200ppm | |
Methanol | ≤3000ppm | ||
Dichloromethane | ≤600ppm | ||
Bulk density | 0.35~0.65g/ml | ||
Tapped density | 0.65~0.85g/ml | ||
Particle size distribution | ≥80% 40mesh | ||
function | Carvedilol has strong heart and neuroprotective effects: unlike normal β-receptor antagonists, long-term use of this product in hypertensive patients can not only dilate coronary and renal vessels, reduce peripheral vascular resistance, but also reduce systemic circulation. And pulmonary circulation resistance, effectively control high blood pressure. This product has a protective effect on renal function, does not change renal blood flow, but reduces microalbuminuria, reduces renal vascular resistance, and has a good regulatory effect on blood lipids. |