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  • Ivabradine Hcl Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Ivabradine HCL CAS No: 148849- 67- 6

    Batch No: IVA/ 011114 A. R. No 14/ FP/ IVA/ 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 powder

    2. Identification Complies HPLC

    3. Residue on ignition 0.08% NMT 0.2%

    4. Loss on drying 0.37% NMT 1.0%

    5. Water 0.53% NMT 2.0%

    6. Heavy metals Complies NMT 20 PPM

    7. Specific rotation +7.4º +6.5º to +8.5º

    8. Related substances

    Single impurity

    Total impurities

    Isomer

    0.07%

    0.21%

    Unetected

    NMT 0.5%

    NMT 1.0%

    NMT 0.1%

    9. Assay 100.2% NLT 98.0%

    .

    Ivabradine

    Ivabradine Structural Formulae V. 1. svg

    Ivabradine ball- and- stick. png

    Systematic ( IUPAC) name

    3- [ 3- ( { [ ( 7S) - 3, 4- dimethoxybicyclo[ 4.2.0] octa- 1, 3, 5- trien- 7- yl] methyl} ( methyl) amino) propyl] - 7, 8- dimethoxy- 2, 3, 4, 5- tetrahydro- 1H- 3- benzazepin- 2- one

    Clinical data

    AHFS/ Drugs. com International Drug Names

    Licence data EMA: Link

    Pregnancy

    category

    AU: D

    Legal status

    UK: Prescription- only ( POM)

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability 40%

    Protein binding 70%

    Metabolism Hepatic ( first- pass) >50% , CYP3A4- mediated

    Biological half- life 2 hours

    Excretion Renal and fecal

    Identifiers

    CAS Registry Number 155974- 00- 8

    ATC code C01EB17

    PubChem CID: 132999

    IUPHAR/ BPS 2357

    ChemSpider 117373 Yes

    UNII 3H48L0LPZQ Yes

    KEGG D07165 Yes

    ChEBI CHEBI: 85966 Yes

    ChEMBL CHEMBL471737 Yes

    Chemical data

    Formula C27H36N2O5

    Molecular mass 468.585 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 9, 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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