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  • Phenytoin Sodium Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Phenytoin Sodium USP CAS No: 630- 93- 3

    Batch No: PHE/ 030313 A. R. No 13/ FP/ PHE/ 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) Sodium: It meets the requirements of the Flame Test.

    4. Related Substances

    Individual Impurity Total Impurity

    0.38%

    0.61%

    NMT 0.9%

    NMT 2.0%

    5. Loss on drying 1.2% NMT 2.5%

    6. Heavy Metals Complies 20ppm

    7. Assay HPLC 99.37% 98.0% –102.0%

    Phenytoin

    Structural formula of phenytoin

    Ball- and- stick model of the phenytoin molecule

    Systematic ( IUPAC) name

    5, 5- diphenylimidazolidine- 2, 4- dione

    Clinical data

    Trade names Dilantin, Phenytek, others[ 1]

    AHFS/ Drugs. com monograph

    MedlinePlus a682022

    Pregnancy

    category

    AU: D

    US: D ( Evidence of risk)

    Legal status

    AU: Prescription Only ( S4)

    CA: ℞ - only

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Oral, parenteral

    Pharmacokinetic data

    Bioavailability 70- 100% oral, 24.4% for rectal and intravenous administration

    Protein binding 95% [ 1]

    Metabolism liver

    Onset of action 10 to 30 min ( IV) [ 2]

    Biological half- life 10–22 hours[ 1]

    Duration of action 24 hr[ 2]

    Excretion Primarily through the bile, urinary

    Identifiers

    CAS Registry Number 57- 41- 0 Yes

    ATC code N03AB02

    PubChem CID: 1775

    IUPHAR/ BPS 2624

    DrugBank DB00252 Yes

    ChemSpider 1710 Yes

    UNII 6158TKW0C5 Yes

    KEGG D00512 Yes

    ChEBI CHEBI: 8107

    ChEMBL CHEMBL16

    Chemical data

    Formula C15H12N2O2

    Molecular mass 252.268 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 12, 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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