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  • Finasteride Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Finasteride USP CAS No: 98319- 26- 7

    Batch No: FIN/ 030313 A. R. No 13/ FP/ FIN/ 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 a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

    Complies b) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

    4. Related Substances

    Individual Impurity Total Impurity

    0.24 %

    0.39%

    NMT 0.5%

    NMT 1.0%

    5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) - 57º Between - 56.0° to - 60.0°,

    6. Heavy Metals Complies 10ppm

    7. Water Content by KF 0.09% NMT 0.3%

    8. Residue On Ignition 0.043% NMT 0.1%

    9. Assay HPLC 99.24% 98.5% –101.0%

    .

    Finasteride

    Finasteride. svg

    Finasteride- 3D- balls. png

    Systematic ( IUPAC) name

    N- ( 1, 1- dimethylethyl) - 3- oxo-

    ( 5α , 17β ) - 4- azaandrost- 1- ene- 17- carboxamide

    Clinical data

    Trade names Propecia, Proscar

    AHFS/ Drugs. com monograph

    MedlinePlus a698016

    Pregnancy

    category

    X ( will cause birth defects in a fetus)

    Legal status

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability 63%

    Metabolism Hepatic

    Biological half- life Elderly: 8 hours

    Adults: 6 hours

    Excretion Feces ( 57% ) and urine ( 39% ) as metabolites

    Identifiers

    CAS Registry Number 98319- 26- 7 Yes

    ATC code G04CB01 D11AX10

    PubChem CID: 57363

    IUPHAR/ BPS 6818

    DrugBank DB01216 Yes

    ChemSpider 51714 Yes

    UNII 57GNO57U7G Yes

    KEGG D00321 Yes

    ChEBI CHEBI: 5062 Yes

    ChEMBL CHEMBL710 Yes

    Chemical data

    Formula C23H36N2O2

    Molecular mass 372.549 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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