Azithromycin compacted/micro

Category:Active Pharmaceutical Ingredients > Antibiotics > Macrolides
Product Name:Azithromycin compacted/micro
CAS No.:117772-70-0
Standard:ChP, BP, EP
Price(USD):1~10
Company:Arshine Group Co.,Ltd.

Basic Info
  • Grade: Pharmaceutical Grade

    Factory Location: Block 14, No.100, Luyun Road, Changsha 410205, Hunan, China.

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

  • Sample Provided: yes

    Payment Terms: L/C

    Discover the advanced and highly effective antibiotic Azithromycin – your ally in the fight against bacterial infections. Specially formulated to target a wide range of bacteria, this groundbreaking medication provides rapid relief and aids in restoring your health. Embrace the power of Azithromycin to combat infections and regain control of your well-being.

    What is Azithromycin?

    Azithromycin belongs to the class of macrolide antibiotics, known for their potent antibacterial properties. This remarkable medication is designed to treat various bacterial infections affecting the respiratory system, skin, and other parts of the body. As a broad-spectrum antibiotic, Azithromycin can effectively tackle a diverse range of harmful bacteria.

    How Does Azithromycin Work?

    Azithromycin works by inhibiting bacterial protein synthesis, a crucial process required for bacteria to grow and multiply. By targeting specific components within bacterial cells, this antibiotic disrupts their ability to reproduce, ultimately leading to bacterial death. Its unique mode of action ensures swift and reliable results, offering rapid relief from the discomforts of bacterial infections.

    Key Features and Benefits:

    1:Broad-Spectrum Action: Azithromycin exhibits efficacy against various bacteria, making it an invaluable tool in combatting a wide array of infections.

    2:Convenience of Dosage: With its extended half-life, Azithromycin often requires shorter treatment durations and less frequent dosing, ensuring improved patient compliance.

    3:Respiratory Infections: Azithromycin is particularly effective in treating respiratory infections, including bronchitis, pneumonia, and sinusitis, alleviating symptoms and promoting recovery.

    4:Skin and Soft Tissue Infections: From mild to moderate skin infections, Azithromycin helps eliminate bacteria responsible for cellulitis, impetigo, and other skin-related concerns.

    5:Sexually Transmitted Infections (STIs): Azithromycin is a recommended treatment for certain STIs, such as chlamydia, offering a swift resolution for affected individuals.

     

    The product name

    Azithromycin

    Batch No.

    C0801-202211004

    Inspection Basis

    USP 43

    Producing Date

    Nov.03,2022

    Retest Date

    Nov.02,2025

    Packing

    25kg/drum

    Amount

    1104.46kg

     

    Items

     

    Appearance

    Identification

    -Infrared absorption

     

     

    -Liquid chromatograph

     

     

    Optical rotation

    Crystallinity

    pH

    Water

    Related  substances  (Procedure  2)(HPLC)

    -AzithromycinN-oxide

    -3'- (N,N-Didemethyl)-3'-N-formyl-azithromycin

    -3'- (N,N-Didemethyl) azithromycin

    (aminoazithromycin)

    -Azithromycin related compound F

    -Desosaminylazithromycin

    -3'-N- {[4- (Acetylamino)phenyl]sulfonyl}-3',3'- didemethylazithromycin

    -N-Demethylazithromycin

    -Azithromycin  C(3"-O-demethylazithromycin) -3'-De(dimethylamino)-3'-oxoazithromycin

    -3'-N- {[4- (Acetylamino)phenyl]sulfonyl}-3'-

    demethylazithromycin

    -Azaerythromycin  A

    -Azithromycin impurity P

    -2-Desethyl-2-propyl-azithromycin

    -3'-N-Demethyl-3'-N-[(4-methylphenyl) sulfonyl]azithromycin

    -3-Deoxyazithromycin(azithromycin  B)

    -Erythromycin A iminoether

    -Erythromycin A oxime

    The items and results of Inspection Specification

     

    White or almost white powder.

     

     

    Corresponds to RS.

     

    The retention time of azithromycin

    peak of the sample solution

    corresponds to that of the standard 

    solution obtained in the Assay.

     

    -45°~-49°

    Meets the requirement.

    9.0~11.0

    4.0~5.0%

    ≤0.5%

    ≤0.5%

     

    ≤0.5%

    ≤0.5%

    ≤0.3%

    ≤0.15%

    ≤0.5%

    ≤0.5%

    ≤0.5%

    ≤0.5%

    ≤0.5%

    ≤0.2%

    ≤0.5%

    ≤0.2%

    ≤1.0%

    ≤0.5%

    ≤0.5%

     

     

    Test results

    white   powder.

     

    Corresponds to RS

    The retention time of

    azithromycin peak of the

    sample solution corresponds

    to that of the standard  solution 

    obtained in the Assay.

    -47°

    Meets the requirement.

    10.0

    4.6%

     

    N.D.

    N.D.

     

    N.D.

    N.D.

    N.D.

    N.D.

    N.D.

    N.D.

    N.D.

     

    N.D.

    N.D

    N.D.

    N.D.

    N.D.

    0.33%

    N.D.

    N.D.

    -Any individual, unidentified

    impurity

    -Total impurities

    Residue on ignition

    Assay (HPLC, on anhydrous basis)

    Additional test:

    Residual solvent(GC)

    -Methanol

    -Ethanol

    -Acetone

    -Dichloromethane

    Bulk density

    Tapped density

    Particle size (D0.1)

    (D0.5)

    (D0.9)

    ≤0.2%

    ≤3.0%

    ≤0.2%

    945~1030μg/mg

     

     

     

    ≤3000 ppm

    ≤5000 ppm

    <5000  ppm

    ≤600 ppm

    0.10%

    0.43%

    0.050%

    997μg/mg

     

     

     

    N.D.

    N.D.

    712ppm

    N.D.

    0.60g/ml

    0.74g/ml

    27.5μm

    80.0μm

    219.9μm

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