Azithromycin CAS 83905-01-5 Supplier / Manufacturer / Pharmaceutical Raw Materials/ Pharmaceutical Intermediate
Details:
Product name: Azithromycin
Alias: 9-Deoxo-9a-methyl-9a-aza-homoerythromycin A;11-(4-Dimethylamino-3-hydroxy-6-methyl-oxan-2-yl)oxy-2-ethyl-3,4,10-tr
CAS NO.: 83905-01-5
MF: C38H72N2O12
MW: 748.99
MS:
Melting Point: 113-115ºC
Appearance: White crystalline powder
Grade: Pharmaceutical Grade & Veterinary Grade
Storage: Closed, shading preservation
Usage: Antibiotics used for a variety of sensitive bacterial infections, such as respiratory infection; skin and soft tissue infection.
Description:
Azithromycin (trade names Zithromax, Azyth, Sumamed) is an antibiotic useful for the treatment of bacterial infections. It is an azalide, a subclass of macrolide antibiotic. It is derived from erythromycin, with a methyl-substituted nitrogen atom incorporated into the lactone ring, thus making the lactone ring 15-membered. Azithromycin is somewhat more potent against certain bacterial species than erythromycin, but its widespread popularity arises primarily from its slow elimination from the body, which allows many infections to be treated with 3-5 days of once-daily administration, compared to 3-4 times a day for up to two weeks for erythromycin.
Azithromycin inhibits the growth of bacteria by interfering with their protein synthesis. It binds to the 50S subunit of the bacterial ribosome, and thus inhibits translation of mRNA. This mechanism of action is typical of macrolide antibiotics.
This antibiotic is widely used alone or in combination with other drugs to treat otitis media, pharyngitis, community-acquired respiratory infections (including pneumonia), gastrointestinal infections (such as those caused by eating contaminated food), and gonorrhea.
It is on the World Health Organization's List of Essential Medicines, a list of the most important medications needed in a basic health system.
Applications
Azithromycin is used to treat many different infections, including:
Acute bacterial exacerbations of chronic obstructive pulmonary disease due to H. influenzae, M. catarrhalis, or S. pneumoniae
Acute bacterial sinusitis due to H. influenzae, M. catarrhalis, or S. pneumoniae
Community-acquired pneumonia' due to C. pneumoniae, H. influenzae, M. pneumoniae, or S. pneumoniae
Acute otitis media caused by H. influenzae, M. catarrhalis or S. pneumoniae
Pharyngitis or tonsillitis caused by S. pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy
Uncomplicated skin and skin structure infections due to S. aureus, S. pyogenes, or S. agalactiae
Urethritis and cervicitis due to C. trachomatis or N. gonorrhoeae
Genital ulcer disease (chancroid) in men due to H. ducreyi
Specification
USP26 Standard:
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Test Item
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Analysis Specification
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Result
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Description
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White or almost white crystalline powder, No odor and bitter. Practically insoluble in water, freely soluble in anhydrous ethanol and in methylene chloride.
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Conforms
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Identification
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A: IR: Conforms to the Azithromycin RS spectrum
B: 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 obtained in the Assay.
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Conforms
Conforms
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Specific rotation
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-45°~-49°(Anhydrous substance 20mg/ml dehydrated alcohol)
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-47°
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Crystallinity
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Meets the requirements
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Conforms
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pH
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9.0~11.0 ( 0.1g /50ml methanol-water (1:1))
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10.0
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Water
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4.0%~5.0%
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4.4%
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Residue on Ignition
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≤0.3%
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0.02%
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Heavy metals
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≤0.0025%
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<0.0025%
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Residual solvents
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Methylene Chloride≤600ppm
Acetone≤5000ppm
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Not detected
1159.0ppm
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Assay((HPLC)
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945~1030 μg /mg ( Anhydrous substance)
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965μg /mg
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Conclusion
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Conform to USP 26 Standard
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USP36 Standard:
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Item
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Standard
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Result
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Characters
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White crystallinity powder
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Complies
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Identification
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a) Infrared Absorption
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Complies
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b) HPLC
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Complies
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Specific rotation
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-45°~ -49°
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-47°
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Crystallinity
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Meets the requirements
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Complies
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pH
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9.0~11.0
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10.3
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Water
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4.0~5.0%
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4.3%
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Residue on ignition
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≤0.3%
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0.07%
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Heavy metals
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≤25%
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less than0.0025%
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Assay
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945~1030μg/mg (C38H72N2O12)Based on anhydrous substance
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Advantages:
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Azithromycin CAS 83905-01-5 Supplier / Manufacturer / Pharmaceutical Raw Materials/ Pharmaceutical Intermediate
China
