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  • Idebenone Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Idebenone CAS No: 58186- 27- 9

    Batch No: IDE/ 011114 A. R. No 14/ FP/ IDE/ 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 An orange yellow or yellow, crystalline powder.

    2. Identification Complies Comply with the standard

    Comply with the standard

    IR

    3. Solubility Complies Insoluble in water, very soluble in methanol, chloroform, freely soluble in anhydrous alcohol and ethyl acetate.

    4. E

    468 458 to 486

    5. Melting point 53.9ºC to 54.3℃ 52ºC to 55ºC

    6. Loss on drying 0.02% NMT 0.1%

    7. Residue on ignition 0.03% NMT 0.1%

    8. Heavy metals Complies NMT 10 PPM

    9. Impurities 0.7% NMT 0.8%

    10. Assay 99.2% NLT 98.5%

    11. Residual solvents

    Hexane

    Methanol

    Toulene

    0.017%

    ND

    0.021%

    NMT 0.029%

    NMT 0.3%

    NMT 0.089%

    Idebenone

    Idebenone. svg

    Systematic ( IUPAC) name

    2- ( 10- hydroxydecyl) - 5, 6- dimethoxy- 3- methyl-

    cyclohexa- 2, 5- diene- 1, 4- dione

    Clinical data

    Trade names Catena, Raxone, Sovrima

    AHFS/ Drugs. com International Drug Names

    Legal status

    Investigational

    Pharmacokinetic data

    Bioavailability <1% ( high first pass effect)

    Protein binding >99%

    Biological half- life 18 hours

    Excretion Urine ( 80% ) and feces

    Identifiers

    CAS Registry Number 58186- 27- 9 Yes

    ATC code N06BX13

    PubChem CID: 3686

    ChemSpider 3558 Yes

    UNII HB6PN45W4J Yes

    KEGG D01750 Yes

    ChEMBL CHEMBL252556 Yes

    Chemical data

    Formula C19H30O5

    Molecular mass 338.439 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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