Europe style for Tylosin Phosphate 10% Granule - Azithromycin – Tecsun
Europe style for Tylosin Phosphate 10% Granule - Azithromycin – Tecsun Detail:
| 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 | |||
| It is applicable to the following infections caused by sensitive bacteria: bronchitis, pneumonia and other lower respiratory tract infections; skin and soft tissue infections; acute otitis media; sinusitis, pharyngitis, tonsillitis and other upper respiratory tract infections (penicillin is a common drug for the treatment of pyogenic streptococcal pharyngitis It is also a commonly used drug for preventing rheumatic fever. Azithromycin can effectively remove oropharyngeal streptococcus, but there is no data on the efficacy of azithromycin treatment and prevention of rheumatic fever. Azithromycin can be used for simple genital infections caused by Chlamydia trachomatis in male and female sexually transmitted diseases. | |||
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