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  • Axitinib Usp Ep Ip Bp Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Axitinib CAS No:

    Batch No: ATR/ 011114 A. R. No 14/ FP/ ATR/ 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 to off- white powder

    2. Identification

    IR

    HPLC

    Complies

    Complies

    IR chromatograph Conforms to the characteristic peak of R. S.

    The retention time of the major peak in the chromatogram Conforms to the characteristic peak of R. S.

    3. Residue on ignition 0.08% NMT 0.20%

    4. Related substances

    Total impurities

    Single impurity

    0.16%

    0.04%

    NMT 1.0%

    NMT 0.50%

    5. Loss on drying 0.10% NMT 1.0%

    6. Heavy metals Complies NMT 20 PPM

    7. Purity 100.0% NLT 99.0%

    .

    Axitinib

    Axitinib2DACS. svg

    Axitinib3Dan. gif

    Systematic ( IUPAC) name

    N- Methyl- 2- [ [ 3- [ ( E) - 2- pyridin- 2- ylethenyl] - 1H- indazol- 6- yl] sulfanyl] benzamide

    Clinical data

    Trade names Inlyta

    AHFS/ Drugs. com monograph

    MedlinePlus a612017

    Licence data EMA: Link, US FDA: link

    Pregnancy

    category

    AU: D

    US: D ( Evidence of risk)

    Legal status

    AU: Prescription Only ( S4)

    CA: ℞ - only

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability 58% [ 1]

    Protein binding >99% [ 1]

    Metabolism Hepatic ( mostly CYP3A4/ CYP3A5- mediated but with some contributions from CYP1A2, CYP2C19, UGT1A1) [ 1]

    Biological half- life 2.5- 6.1 hours[ 1]

    Excretion Faeces ( 41% ; 12% as unchanged drug) , urine ( 23% ) [ 1]

    Identifiers

    CAS Registry Number 319460- 85- 0 Yes

    ATC code L01XE17

    PubChem CID: 6450551

    IUPHAR/ BPS 5659

    ChemSpider 4953153 Yes

    UNII C9LVQ0YUXG Yes

    KEGG D03218 Yes

    ChEBI CHEBI: 66910

    ChEMBL CHEMBL1289926

    PDB ligand ID AXI ( PDBe, RCSB PDB)

    Chemical data

    Formula C22H18N4OS

    Molecular mass 386.469 g/ mol


    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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