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  • Dantrolene Sodium Usp - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Dantrolene Sodium USP CAS No: 24868- 20- 0

    Batch No: DAN/ 030313 A. R. No 13/ FP/ DAN/ 0303

    Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

    Batch Quantity 165 kg Date of Retest Jan- 2016

    Sr. No Test Results Acceptance Criteria

    1. Appearance

    2. Solubility

    3. Identification

    Complies a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

    Complies b) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

    Complies c) Sodium: meets the requirements of the flame test for sodium.

    4. Related Substances

    Total Impurity

    0.05%

    NMT 0.15%

    5. Water Content by KF 14.7% 14.5% –17.0%

    6. Heavy metals Complies NMT 20ppm

    7. Assay HPLC 94.27% 90.0% –96.0%

    Dantrolene

    Structural formula of dantrolene

    Space- filling model of the dantrolene molecule

    Systematic ( IUPAC) name

    1- { [ 5- ( 4- nitrophenyl) - 2- furyl] methylideneamino}

    imidazolidine- 2, 4- dione

    Clinical data

    Trade names Dantrium

    AHFS/ Drugs. com monograph

    Pregnancy

    category

    US: C ( Risk not ruled out)

    Routes of

    administration Oral, intravenous

    Pharmacokinetic data

    Bioavailability 70%

    Metabolism Liver

    Excretion Biliary, renal

    Identifiers

    CAS Registry Number 7261- 97- 4 Yes

    ATC code M03CA01

    PubChem CID: 2952

    IUPHAR/ BPS 4172

    DrugBank DB01219 Yes

    ChemSpider 2847 Yes

    UNII F64QU97QCR Yes

    KEGG D02347

    ChEBI CHEBI: 4317 Yes

    ChEMBL CHEMBL1201288

    Chemical data

    Formula C14H10N4O5

    Molecular mass 314.253 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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