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  • Modafinil Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Modafinil CAS No: 68693- 11- 8

    Batch No: MOD/ 011114 A. R. No 14/ FP/ MOD/ 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 almost white crystal powder

    2. Solubility Complies Very slightly soluble or practically insoluble in water springly soluble in methanol slightly soluble in ethanol

    3. Melting point 164ºC to 165ºC 163ºC to 165ºC

    4. Identification Complies IR

    5. Related substances

    Impurity A

    Impurity B

    Unspecified impurities

    Total impurity

    0.05%

    0.03%

    0.02%

    0.1%

    NMT 0.2%

    NMT 0.5%

    NMT 0.1%

    NMT 1.0%

    6. Loss on drying 0.18% NMT 0.5%

    7. Sulphated ash 0.05% NMT 0.1%

    8. Heavy metals Complies NMT 10 PPM

    9. Assay 99.6% 98% to 102%

    .

    Modafinil2DACS. svg

    Armodafinil ball- and- stick xtal 2013. png

    Systematic ( IUPAC) name

    2- benzhydrylsulfinylethanamide

    Clinical data

    Trade names Alertec, Modavigil, Modiodal, Provigil, Modalert

    AHFS/ Drugs. com monograph

    MedlinePlus a602016

    Licence data US FDA: link

    Pregnancy

    category

    AU: B3

    US: C ( Risk not ruled out)

    Legal status

    AU: Prescription Only ( S4)

    CA: Schedule F

    UK: Prescription- only ( POM)

    US: Schedule IV

    Dependence

    liability low

    Addiction

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability Not determined due to the aqueous insolubility

    Protein binding 62%

    Metabolism Hepatic ( primarily via amide hydrolysis; [ 1] CYP1A2, CYP3A4, and CYP2B6) [ 2]

    Biological half- life 15 hours ( R- enantiomer) ,

    4 hours ( S- enantiomer) [ 3]

    Excretion Urine ( 80% )

    Identifiers

    CAS Registry Number 68693- 11- 8 Yes

    ATC code N06BA07

    PubChem CID: 4236

    IUPHAR/ BPS 7555

    DrugBank DB00745 Yes

    ChemSpider 4088 Yes

    UNII R3UK8X3U3D Yes

    KEGG D01832 Yes

    ChEBI CHEBI: 31859

    ChEMBL CHEMBL1373 Yes

    Chemical data

    Formula C15H15NO2S

    Molecular mass 273.35 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 10, 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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