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  • Ketoconazole Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Ketoconazole USP CAS No: 65277- 42- 1

    Batch No: KET/ 030313 A. R. No 13/ FP/ KET/ 0303

    Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

    Batch Quantity 165 kg Date of Retest Jan- 2016

    Sr. No Test Results Acceptance Criteria

    1. Appearance

    2. Solubility

    3. Identification

    Complies By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

    4. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +0.12º Between - 1° to +1°

    5. Loss on drying 0.17% NMT 0.5%

    6. Heavy Metals Complies 20ppm

    7. Residue On Ignition 0.0076% NMT 0.1%

    8. Assay 99.43% 98.0% –102.0%

    9. Melting Temperature 151º 148°–152°

    . .

    Ketoconazole

    Ketoconazole2DACS. svg

    Systematic ( IUPAC) name

    1- [ 4- ( 4- { [ ( 2R, 4S) - 2- ( 2, 4- Dichlorophenyl) - 2- ( 1H- imidazol- 1- ylmethyl) - 1, 3- dioxolan- 4- yl] methoxy} phenyl) piperazin- 1- yl] ethan- 1- one

    Clinical data

    Trade names Nizoral

    AHFS/ Drugs. com monograph

    MedlinePlus a682816

    Licence data US FDA: link

    Pregnancy

    category

    AU: B3

    US: C ( Risk not ruled out)

    Legal status

    UK: Prescription- only ( POM)

    US: OTC

    Routes of

    administration Oral, topical

    Pharmacokinetic data

    Bioavailability Variable

    Protein binding 84 to 99%

    Metabolism Hepatic

    Biological half- life Biphasic

    Excretion Biliary and renal

    Identifiers

    CAS Registry Number 65277- 42- 1 Yes

    ATC code J02AB02 D01AC08 G01AF11

    PubChem CID: 456201

    IUPHAR/ BPS 2568

    DrugBank DB01026 Yes

    ChemSpider 401695 Yes

    UNII R9400W927I Yes

    KEGG D00351 Yes

    ChEBI CHEBI: 48336 Yes

    ChEMBL CHEMBL75 Yes

    PDB ligand ID KTN ( PDBe, RCSB PDB)

    Chemical data

    Formula C26H28Cl2N4O4

    Molecular mass 531.431 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 9, 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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