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  • Aprepitant Usp Ip Ep Bp Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Aprepitant CAS No: 170729- 80- 3

    Batch No: APR/ 011114 A. R. No 14/ FP/ APR/ 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 Off- white to light yellow powder

    2. Specific optical rotation 67.49° +68.0° ±3° ( c=1.0, in Methanol)

    3. Identification

    Complies IR, HPLC

    4. Melting point 248°C to 250°C 248±5 °C

    5. Water 0.29% NMT 0.5%

    6. Heavy metals Complies NMT 10 PPM

    7. Residue on ignition 0.07% NMT 0.1%

    8. Enantiomer purity 0.07% NMT 0.15% S, R, S- enantiomer

    9. Related substances

    Desfluoro aprepitant

    R, R, R- Diastereomer

    Any other individual impurity

    Total impurities

    0.09%

    0.08%

    0.06%

    0.29%

    NMT 0.15%

    NMT 0.10%

    NMT 0.50%

    10. Assay 99.9% 98.0% to 102.0%

    11. Organic volatile impurities Complies Methanol NMT 2500 ppm; Xylene NMT

    2170 ppm; Toluene NMT 890 ppm; DMSO

    NMT 5000ppm

    . .

    Aprepitant

    Structural formula of aprepitant

    Ball- and- stick model of the aprepitant molecule

    Systematic ( IUPAC) name

    5- ( [ ( 2R, 3S) - 2- ( ( R) - 1- [ 3, 5- bis( trifluoromethyl) phenyl] ethoxy) - 3- ( 4- fluorophenyl) morpholino] methyl) - 1H- 1, 2, 4- triazol- 3( 2H) - one

    Clinical data

    Trade names Emend

    AHFS/ Drugs. com monograph

    MedlinePlus a604003

    Pregnancy

    category

    AU: B1

    US: B ( No risk in non- human studies)

    Legal status

    AU: Prescription Only ( S4)

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability 60- 65%

    Protein binding >95%

    Metabolism Hepatic ( mostly CYP3A4- mediated; some contributions by CYP2C19 & CYP1A2)

    Biological half- life 9- 13 hours

    Excretion Urine ( 5% ) , faeces ( 86% )

    Identifiers

    CAS Registry Number 170729- 80- 3 Yes

    ATC code A04AD12

    PubChem CID: 6918365

    IUPHAR/ BPS 3490

    DrugBank DB00673 Yes

    ChemSpider 5293568 Yes

    UNII 1NF15YR6UY Yes

    ChEBI CHEBI: 499361 Yes

    ChEMBL CHEMBL1471 Yes

    Chemical data

    Formula C23H21F7N4O3

    Molecular mass 534.427 g/ mo


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 5, 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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