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  • Repaglinide Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name REPAGLINIDE CAS No:

    Batch No: REP/ 011114 A. R. No 14/ FP/ REP/ 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. Identification + 6.7° Rotation +6.3° to +7.7°

    3. RS correspond to the reference substance Should correspond to the RS infrared absorption

    4. Related substance

    Individual impurity

    Total impurity

    0.05%

    0.14%

    NMT 0.1%

    NMT 0.5%

    5. Enantiomeric impurity Not detected NMT 0.2%

    6. Dichlormethane

    Ethanol

    Methanol Not detected

    Not detected

    Not detected NMT 0.06%

    NMT 0.3%

    7. Assay 100.1% 99.0% to 101.0%

    8. Residue on ignition Complies NMT 0.1%

    9. Loss on drying 0.06% NMT 0.5%

    Repaglinide

    Repaglinide. svg

    Repaglinide ball- and- stick. png

    Systematic ( IUPAC) name

    ( S) - ( +) - 2- ethoxy- 4- [ 2- ( 3- methyl- 1- [ 2- ( piperidin- 1- yl) phenyl] butylamino) - 2- oxoethyl] benzoic acid

    Clinical data

    Trade names Prandin

    AHFS/ Drugs. com monograph

    MedlinePlus a600010

    Licence data EMA: Link, US FDA: link

    Pregnancy

    category

    AU: C

    US: C ( Risk not ruled out)

    Legal status

    AU: Prescription Only ( S4)

    CA: ℞ - only

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability 56% ( oral)

    Protein binding >98%

    Metabolism Hepatic oxidation and glucuronidation ( CYP3A4- mediated)

    Biological half- life 1 hour

    Excretion Fecal ( 90% ) and renal ( 8% )

    Identifiers

    CAS Registry Number 135062- 02- 1 Yes

    ATC code A10BX02

    PubChem CID: 65981

    IUPHAR/ BPS 6841

    DrugBank DB00912 Yes

    ChemSpider 59377 Yes

    UNII 668Z8C33LU Yes

    KEGG D00594 Yes

    ChEMBL CHEMBL1272 Yes

    Chemical data

    Formula C27H36N2O4

    Molecular mass 452.586 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 14, 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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