Roxithromycin 80214-83-1 C41H76N2O15
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Function:
Roxithromycin is a semi-synthetic macrolide antibiotic. It is used to treat respiratory tract, urinary and soft tissue infections. Roxithromycin is derived from erythromycin, containing the same 14-membered lactone ring. However, an N-oxime side chain is attached to the lactone ring. It is also currently undergoing clinical trials for the treatment of male-pattern hair loss.
1.Macrolide antibiotics, erythromycin derivatives, antibacterial spectrum and erythromycin similar, but the role of 6 times stronger than erythromycin, bioavailability. For respiratory infections such as pneumonia, acute bronchitis, acute exacerbation of chronic bronchitis, atypical pneumonia, and genitourinary infections, skin and soft tissue infections, have good therapeutic effect and tolerance, adverse reactions than erythromycin Small.
2. This product is a new generation of macrolide antibiotics, mainly for Gram-positive bacteria, anaerobic bacteria, chlamydia and mycoplasma. Its antibacterial activity in vitro and erythromycin similar to the role of the body stronger than erythromycin 1-4 times.
3. In clinical medicine for drug-resistant Staphylococcus aureus and hemolytic streptococcus caused by the preferred drug, veterinary clinical treatment of penicillin-resistant, Staphylococcus aureus caused by severe infections, pneumonia, metritis, chronic respiratory disease of fowls Wait.
4. Mainly used for the treatment of chronic respiratory disease in livestock and poultry, Staphylococcus aureus and streptococcal disease, chlamydia, spirochaetosis (swine dysentery), infectious pleurisy, rhinitis and so on.
Name of product | Roxithromycin hcl | |
EXP. Time | 3 years | |
Analysis content | Analysis results | Standard |
Appearance | White or almost white crystalline powder | white crystalline powder |
Identification | 1) IR: conforms to the Roxithromycin CRS specturm | Meets the requirements |
2) HPLC: Similar inreatention time and size to the principal peak of the reference solution | conforms | |
Appearance of solution | clear and colourless | conforms |
Specific Rotation | between -93º-96º | -95º |
Assay(HPLC) | 99.69% | 99.0~100% |
Related substances | 1) Impurity G% less than 1.0% | 0.09% |
2) Impurity A,B,C,D,E,F,H,I,J less than 0.5% | 0.31% | |
3)Total Impurities less than 3.0% | 1.7% | |
Heavy metals | less than 10ppm | <10ppm |
water | less than 3.0% | 2.2% |
Sulphated ash | less than 0.1% | 0.02% |
Residual solvents | methanol less than 3000PPM | 286PPM |
acetone less than 5000ppm | not detected | |
methylene chloride less than 600ppm | not detected | |
Conclusion: | Complies with requirements of EP8.0 |
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