ПРОДУКТ
Roxithromycin
| Chemical Name | : Roxithromycin |
| Category | : Macrolide antibiotics |
| Specification | : EP |
| HS Code | : 29415000.00 |
- Телефон: +86-532-83876123
- Факс: +86-532-83876157
- Email: dennis@qingmeibio.com
- Skype: dennis10221
ХИМИЧЕСКАЯ ХАРАКТЕРИСТИКА
| Structure Formula | :  |
| CAS Number | : 56180-94-0 |
| Molecular Formula | : C41H76N2O15 |
| Usage | : The product is a new generation of macrolide antibiotics, mainly for gram positive bacteria, anaerobic bacteria, chlamydia and mycoplasma. The in vitro antibacterial activity of erythromycin and similar, in vivo 1-4 times stronger than that of erythromycin. The pharmacological effects and indications of 1, gram negative bacteria have a strong killing effect, part of the gram negative bacteria (Neisseria meningitidis, Neisseria gonorrhoeae, influenza bacillus, Bacillus pertussis, Brucella) and the spiral body, Mycoplasma pneumoniae, Legionella bacteria, Rickettsia, Chlamydia Mycoplasma sensitivity, enhancement of the role. 2, antibacterial mechanism: combined with bacterial control 50S protein subunit, by blocking on the displacement of transpeptidation and MRNA, the inhibition of protein synthesis. 3, the product of good oral absorption, quick effect, bioavailability and drug concentration in the blood were stronger than that of erythromycin. According to reports, oral 150mg peak plasma concentrations as high as 6.6 ~ 7.9ug/ml, and under the same conditions of erythromycin is only 0.2 ~ 0.4ug/ml; roxithromycin mainly distributed in body fluids and tissues, with high and persistent tissue concentration and cell concentration, while the half-life of up to 12h, and erythromycin is only 1.5 ~ 2.0h. 4, in clinical medicine as the preferred drug induced resistant Staphylococcus aureus and hemolytic streptococci, veterinary clinic for treatment, caused by penicillin resistant Staphylococcus aureus pneumonia, serious infections, metritis, avian chronic respiratory disease. 5, the product is mainly used for the treatment of chronic respiratory disease of livestock and poultry, livestock and poultry Staphylococcus and streptococcus disease, chlamydia, leptospirosis (Zhu Liji), infectious pleuropneumonia, rhinitis etc.. 6, indications of performance: Bird neck swelling, local heat, pain, difficulty breathing, mouth nose flow of white foam, mucous membrane and skin cyanosis and other symptoms. |
ТЕХНИЧЕСКИЙ ПАРАМЕТР
| Items | Standard |
|---|---|
| Appearance | |
| Solubility | |
| Identification | |
| Appearance of solution | |
| Related substances | |
| Impurity B | ≤0.0% |
| Impurity P | ≤0.0% |
| Impurity C | ≤0.0% |
| Impurity N | ≤0.0% |
| Impurity O | ≤0.0% |
| Impurity I | ≤0.0% |
| Impurity J | ≤0.0% |
| Impurity F | ≤0.0% |
| Impurity A | ≤0.0% |
| Impurity K | ≤0.0% |
| Impurity G | ≤0.0% |
| Any other impurity | ≤0.0% |
| Total impurities | ≤% |
| Water | ≤3.0% |
| Sulphated Ash | ≤0.1% |
| Residual Solvent | ≤0.1% |
| Toluene | ≤ppm |
| Assay (On the anhydrous basis) | ≥94.0% ( C11H76N2O15) |
ЗАРЕГИСТРИРОВАННЫЕ ДОКУМЕНТЫ
The available documents are:
Chinese GMP
CEP
DMF/CTD format
The available registered countries are:
Algeria
Spain
Australia
Chinese GMP
CEP
DMF/CTD format
The available registered countries are:
Algeria
Spain
Australia