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  • Darifenacin Hydrobromide Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Darifenacin hydrobromide CAS No: 133099- 07- 7

    Batch No: DAR/ 011114 A. R. No 14/ FP/ DAR/ 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 almost white crystalline powder

    2. Specific optical rotation +46.43° +44° to + 48°

    3. Melting point 227.5℃ to 231.0℃ 227℃ to 232℃

    4. Loss on drying 0.22% NMT 1.0%

    5. Residue on ignition 0.05% NMT 0.1%

    6. Heavy metals Complies NMT 20 PPM

    7. Total impurities 0.36% NMT 0.5%

    8. Single known impurity 0.11% NMT 0.3%

    9. Single unknown impurity Complies NMT 0.2%

    10. Residual solvents

    Acetone

    Methanol

    Complies

    Complies

    NMT 5000 PPM

    NMT 3000 PPM

    11. Assay 100.8% NLT 98.5%

    Darifenacin

    Darifenacin. svg

    Darifenacin- hydrobromide- from- xtal- 2009- CM- 3D- balls. png

    Systematic ( IUPAC) name

    ( S) - 2- [ 1- [ 2- ( 2, 3- dihydrobenzofuran- 5- yl) ethyl] pyrrolidin- 3- yl] - 2, 2- diphenyl- acetamide

    Clinical data

    Trade names Enablex

    AHFS/ Drugs. com monograph

    MedlinePlus a605039

    Pregnancy

    category

    AU: B3

    US: C ( Risk not ruled out)

    Legal status

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability 15 to 19% ( dose- dependent)

    Protein binding 98%

    Metabolism Hepatic ( CYP2D6- and CYP3A4- mediated)

    Biological half- life 13 to 19 hours

    Excretion Renal ( 60% ) and biliary ( 40% )

    Identifiers

    CAS Registry Number 133099- 04- 4 Yes

    ATC code G04BD10

    PubChem CID: 444031

    IUPHAR/ BPS 321

    DrugBank DB00496 Yes

    ChemSpider 392054 Yes

    UNII APG9819VLM Yes

    KEGG D01699

    ChEBI CHEBI: 391960 Yes

    ChEMBL CHEMBL1346 Yes

    Chemical data

    Formula C28H30N2O2

    Molecular mass 426.55 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 7, 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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