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  • Bicalutamide Usp Ip Ep Bp Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Bicalutamide CAS No:

    Batch No: BIC/ 011114 A. R. No 14/ FP/ BIC/ 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 off- white crystalline powder

    2. Solubility Complies Freely soluble in tetrahydrofuran and in acetone; soluble in acetonitrile; sparingly soluble in methanol slightly soluble in alcohol soluble

    3. Identification Complies

    Complies IR

    HPLC

    4. Water content 0.05% NMT 0.2%

    5. Residue on ignition 0.08% NMT 0.1%

    6. Heavy metals Complies NMT 0.001%

    7. Related substance

    Des- fluoro analog

    2- Fluoro isomer

    Des hydroxy analog

    Individual unspecified impurity

    Total unspecified impurities

    Total impurities

    0.04%

    Not detected

    0.03%

    0.07%

    0.19%

    0.29%

    0.2% Max

    0.1% Max

    0.3% Max

    0.5% Max

    8. Assay 99.8% 98.0% to 102.0%

    9. Related substances

    Dichloromethane

    Ethanol

    Complies

    Complies

    600ppm Max

    5000ppm Max

    . .

    Bicalutamide

    Bicalutamide. svg

    Bicalutamide ball- and- stick. png

    Systematic ( IUPAC) name

    N- [ 4- cyano- 3- ( trifluoromethyl) phenyl] - 3- [ ( 4- fluorophenyl) sulfonyl] - 2- hydroxy- 2- methylpropanamide

    Clinical data

    Trade names Casodex

    AHFS/ Drugs. com monograph

    MedlinePlus a697047

    Pregnancy

    category

    US: X ( Contraindicated)

    Legal status

    ℞ ( Prescription only)

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability Well- absorbed

    Protein binding 96%

    Metabolism Hepatic ( CYP3A4)

    Biological half- life 6 days

    Identifiers

    CAS Registry Number 90357- 06- 5 Yes

    ATC code L02BB03

    PubChem CID: 2375

    IUPHAR/ BPS 2863

    DrugBank DB01128 Yes

    ChemSpider 2284 Yes

    UNII A0Z3NAU9DP Yes

    KEGG D00961

    ChEMBL CHEMBL63560

    Synonyms ICI- 176334[ 1]

    PDB ligand ID 198 ( PDBe, RCSB PDB)

    Chemical data

    Formula C18H14F4N2O4S

    Molecular mass 430.373 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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