product Description:
Azithromycin is antibiotics.The antibacterial spectrum of this product is similar to erythromycin, with strong effect on haemophilus influenzae and gonococci, which is 4 times stronger than erythromycin.Twice as strong for legionella;For the vast majority of gram-negative bacteria, the effect on clostridium difficile is also stronger than erythromycin, in the application of staphylococcus aureus infection is also more effective than erythromycin.In addition, this product also has a good killing effect on toxoplasmosis, treponema pallidum.
Specification
Items | Specifications | Results |
Appearance | White or almost white powder | White powder |
Solubility | Practically insoluble in water, freely soluble in anhydrous ethanol and in methylene chloride | Conforms |
Idetification | 1) IR: Conforms to the spectrum of Azithromycin RS | Conforms |
2) HPLC: The retention time of azithromycin peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the Standard preparation, as ovtained in the assay | ||
Specific rotation | -45°~ -49° | -47° |
Crystallinity | Meets the requirements | Conforms |
pH | 9.0~11.0 (2mg/ml methanol-water(1:1)) | 10.1 |
Water | 4.0%~5.0% | 4.60% |
Residue on ignition | ≤0.3% | 0.01% |
Heavy metals | ≤25ppm | <25ppm |
Impurity A ≤0.5% | Not detected | |
Impurity B ≤1.0% | 0.40% | |
Impurity C ≤0.5% | 0.22% | |
Impurity J ≤0.3% | 0.11% | |
Impurity E ≤0.5% | Not detected | |
Impurity F ≤0.5% | <0.10% | |
Impurity G ≤0.5% | Not detected | |
Related Substances(HPLC Test 2) | Impurity I ≤0.7% | Not detected |
Impurity L≤0.5% | Not detected | |
Impurity M≤0.5% | Not detected | |
Impurity N ≤0.5% | Not detected | |
Impurity O≤0.5% | 0.11% | |
Impurity P ≤0.2% | <0.10% | |
Any other impuirty ≤0.2% | <0.10% | |
Total impurities ≤3.0% | 0.84% | |
Residual Solvents | Methylene Chlorde≤600ppm | Not detected |
Acetone ≤5000ppm | 330ppm | |
Assay | 945~1030μg/mg (Anhydrous substance ) | 978μg/mg |
Conclusion | The results can conforms with the USP37 standard. |
Application
1.Azithromycin is used to treat or prevent certain bacterial infections, most often those causing middle ear i nfections, strep throat, pneumonia, typhoid, and sinusitis;
2.It has been used primarily to prevent bacterial infections in infants and those with weaker immune system
3.It is also effective against certain sexually transmitted infections, such as non- gonococcal urethritis, chlamydia, and cervicitis;
4.Azithromycin is used for acute pharyngitis, acute tonsillitis caused by Streptococcus pyogenes;
5.Azithromycin is used for acute throat and tonsillitis which are caused by streptococcus pyogenes, otitis;
6.Azithromycin can treatment of media sinusitis acute bronchitis skin soft tissue infection which are caused by sensitive bacteria;
7.Azithromycin is also used for pneumonia urethritis cervicitis and so on.
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