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  • Azithromycin Dihydrate Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Azithromycin Dihydrate CAS No:

    Batch No: AZI/ 011114 A. R. No 14/ FP/ AZI/ 0111

    Date of Manufacture Nov- 2014 Date of Analysis 02- 11- 14

    Batch Quantity 100 kg Date of Retest Jan- 2017

    Sr. No Test Results Acceptance Criteria

    1. Appearance Complies White or almost crystalline Powder

    2. Identification

    IR

    HPLC

    Complies

    Complies

    A. Conforms to the reference spectrum

    B. Similar in retention time and size to the principal peak of the reference

    3. Specific optical rotation - 47.0° - 45° to - 49°

    4. Clarity of solution Complies Not more intensely turbid than reference suspensions II

    5. PH 9.9 9.0 to 11.0

    6. Crystallinity Complies Should conforms to requirements

    7. Related substances

    Desosaminylazithromycin

    N- demothylazithromycin

    Other impurity

    Total impurity

    0.07%

    0.35%

    0.34%

    1.1%

    NMT 0.3%

    NMT 0.7%

    NMT 1.0%

    NMT 3.0%

    8. Water content 4.5% 4.0% to 5.0%

    9. Residue on Ignition 0.03% NMT 0.3%

    10. Heavy metals 20 PPM NMT 25 PPM

    11. Undue toxicity Complies Should conforms to requirements

    12. Assay 967.0μ g/ mg 945μ g/ mg~1030μ g/ mg

    . .

    Azithromycin

    Azithromycin structure. svg

    Azithromycin 3d structure. png

    Systematic ( IUPAC) name

    ( 2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R) - 2- ethyl- 3, 4, 10- trihydroxy- 3, 5, 6, 8, 10, 12, 14- heptamethyl- 15- oxo- 11- { [ 3, 4, 6- trideoxy- 3- ( dimethylamino) - β - D- xylo- hexopyranosyl] oxy} - 1- oxa- 6- azacyclopentadec- 13- yl 2, 6- dideoxy- 3- C- methyl- 3- O- methyl- α - L- ribo- hexopyranoside

    Clinical data

    Trade names Zithromax, Azithrocin, others

    AHFS/ Drugs. com monograph

    MedlinePlus a697037

    Licence data US FDA: link

    Pregnancy

    category

    AU: B1

    US: B ( No risk in non- human studies)

    Legal status

    US: ℞ - only

    Routes of

    administration Oral ( capsule, tablet or suspension) , intravenous, ophthalmic

    Pharmacokinetic data

    Bioavailability 38% for 250 mg capsules

    Metabolism Hepatic

    Biological half- life

    11–14 h ( single dose)

    68 h ( multiple dosing)

    Excretion Biliary, renal ( 4.5% )

    Identifiers

    CAS Registry Number 83905- 01- 5 Yes

    ATC code J01FA10 S01AA26

    PubChem CID: 55185

    IUPHAR/ BPS 6510

    DrugBank DB00207 Yes

    ChemSpider 10482163 Yes

    UNII J2KLZ20U1M Yes

    KEGG D07486 Yes

    ChEBI CHEBI: 2955 Yes

    ChEMBL CHEMBL529 Yes

    NIAID ChemDB 007311

    Synonyms 9- deoxy- 9a- aza- 9a- methyl- 9a- homoerythromycin A

    Chemical data

    Formula C38H72N2O12

    Molecular mass 748.984 g· mol− 1


    Company Contact:


    • Phone: 912406641875

    • Address: PLOT NO: 04 JALGAON ROAD, HARSOOL, AURANGABAD, India

    • Email: Email


    Published date: September 5, 2015 -

    • Business Description: We, at SWAPNROOP, are committed to providing affordable Drugs &

      Pharmaceuticals of global quality standards to Pharma Companies all over

      the world. In our warehouse facilities, approved by FDA. we supply

      Pharmaceutical Finished products, Dental products and Active

      Pharmaceutical Ingredients.

      We, at SWAPNROOP, are committed to providing affordable Drugs & Pharmaceuticals of global quality standards to Pharma Companies all over the world. Our warehouse facilities is approved by FDA and we are specializes in sales and marketing of Pharmaceutical Finished products, Pharmaceutical Active Ingredients (API's) and Dental products, providing a wide range of quality and affordable products to a large number of pharmaceutical companies, reputed private and government/semi government organizations/ research centers as well as universities.

      We supply and market over 500 molecules and their combinations in multiple dosage forms, catering to patient needs in various therapies. These include Anti infectives, Cardiovascular, Pain management, Central Nervous System (CNS), Gastrointestinal, Respiratory, Dermatology, Orthopaedics, Nutritionals, Urology and Dental.

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