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  • Fenofibrate Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Fenofibrate CAS No:

    Batch No: FEN/ 011114 A. R. No 14/ FP/ FEN/ 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 crystalline powder

    2. Solubility Complies Practically insoluble in water very soluble in methylene chloride slightly soluble in ethanol 96%

    3. Identification 81ºC

    Complies A) Melting point 79ºC to 82ºC

    B) Infrared absorption spectrophotometery

    4. Appearance of solution Complies The solution is clear and not more intensely coloured than reference solution

    5. Acidity Complies NMT 0.2 ml of 0.1 M sodium hydroxide is required to change the colour of the indicator to pink

    6. Related substances by HPLC

    Impurity A

    Impurity B

    Impurity G

    Unspecified impurities

    Total impurities

    NMT 0.1%

    NMT 0.2%

    NMT 0.10%

    NMT 0.5%

    0.012%

    Not detected

    0.067%

    0.236%

    7. Halides expressed as chlorides 100 PPM NMT 100 PPM

    8. Sulphates 100 PPM NMT 100 PPM

    9. Heavy metals 20 PPM NMT 20 PPM

    10. Loss on drying 0.14% NMT 0.5%

    11. Sulphated ash 0.06% NMT 0.1%

    12. Assay by HPLC 99.764% 98.0% to 102.0%

    . .

    Fenofibrate

    Fenofibrate structure. svg

    Systematic ( IUPAC) name

    propan- 2- yl 2- { 4- [ ( 4- chlorophenyl) carbonyl] phenoxy} - 2- methylpropanoate

    Clinical data

    Trade names Fenoglide, Lipofen

    AHFS/ Drugs. com monograph

    MedlinePlus a601052

    Pregnancy

    category

    US: C ( Risk not ruled out)

    Legal status

    Legend

    Routes of

    administration Oral

    Pharmacokinetic data

    Protein binding 99%

    Metabolism glucuronidation

    Biological half- life 20 hours

    Excretion urine ( 60% ) , feces ( 25% )

    Identifiers

    CAS Registry Number 49562- 28- 9 Yes

    ATC code C10AB05

    PubChem CID: 3339

    IUPHAR/ BPS 7186

    DrugBank DB01039 Yes

    ChemSpider 3222 Yes

    UNII U202363UOS Yes

    KEGG D00565 Yes

    ChEBI CHEBI: 5001 Yes

    ChEMBL CHEMBL672 Yes

    Chemical data

    Formula C20H21ClO4

    Molecular mass 360.831 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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