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  • Febuxostat Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name FEBUXOSTAT CAS No:

    Batch No: FEB/ 011114 A. R. No 14/ FP/ FEB/ 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 almost wlir. teeoloredpowder

    2. Identification( by HPLC) Complies The sample spectrum should

    matches with major functional

    groups.

    3. Solubility Complies Freely soluble in DMF and

    practicallv insoluble in water

    4. Loss on drying 0.20% NMT 1.0%

    5. Sulphated ash 0.06% NMT 0.10%

    6. Heavy metals Complies NMT 20 PPM

    7. Related substances

    Single impurity

    Total impurities

    0.12%

    0.19%

    NMT 0.50%

    NMT 1.0%

    8. Residual solvents

    a) Methanol

    b) Ethanol

    c) Dichloromethane

    d) Acetone

    e) Dimethyl formamaide

    f) Toluene

    3 PPM

    5PPM

    Not detected

    3 PPM

    NMT 3000 PPM

    NMT 5000 PPM

    NMT 600 PPM

    NMT 880 PPM

    NMT 890 PPM

    .

    Febuxostat

    Febuxostat. svg

    Systematic ( IUPAC) name

    2- ( 3- cyano- 4- isobutoxyphenyl) - 4- methyl-

    1, 3- thiazole- 5- carboxylic acid

    Clinical data

    Trade names Uloric, Adenuric, Atenurix, feburic. Generic in several countries. [ 1]

    AHFS/ Drugs. com monograph

    MedlinePlus a609020

    Licence data EMA: Link, US FDA: link

    Pregnancy

    category

    US: C ( Risk not ruled out)

    Legal status

    US: ℞ - only

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability ~49% absorbed

    Protein binding ~99% to albumin

    Metabolism via CYP1A2, 2C8, 2C9, UGT1A1, 1A3, 1A9, 2B7

    Biological half- life ~5- 8 hours

    Excretion Urine ( ~49% mostly as metabolites, 3% as unchanged drug) ; feces ( ~45% mostly as metabolites, 12% as unchanged drug)

    Identifiers

    CAS Registry Number 144060- 53- 7

    ATC code M04AA03

    PubChem CID: 134018

    IUPHAR/ BPS 6817

    ChemSpider 118173 Yes

    UNII 101V0R1N2E Yes

    KEGG D01206 Yes

    ChEMBL CHEMBL1164729 Yes

    Chemical data

    Formula C16H16N2O3S

    Molecular mass 316.374 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 8, 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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