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  • Montelukast Sodium Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name MONTELUKAST SODIUM CAS No: 151767- 02- 1

    Batch No: MON/ 011114 A. R. No 14/ FP/ MON/ 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 pale yellow

    Powder.

    2. Solubility Complies Freely soluble in

    methanol. ethanol, water,

    insoluble in acetonitrile.

    3. Identification Complies Infra red spectrum is

    concordant with that of

    working standerd of

    montelukast sodium.

    4. Loss on drying 0.25% NMT 1.0%

    5. Impurities

    1.0 Dihydro Impurities.

    2.0 Sulphoxide.

    3.0 Styrene.

    4.0 Methyl ketone

    hydroxyl compound.

    5.0 Cis isomer.

    a. Other isomer.

    b. Totol Impurities.

    c. Major Unknown

    Impurities.

    0.08%

    Nil.

    0.21% .

    Nil.

    NMT: 1.0% .

    NMT: 0.15% .

    NMT: 0.1% .

    6. Assay 99.1% 99% to 101%

    Montelukast2DCSD. svg

    Montelukast 3D ball- and- stick. png

    Systematic ( IUPAC) name

    ( R, E) - 2- ( 1- ( ( 1- ( 3- ( 2- ( 7- chloroquinolin- 2- yl) vinyl) phenyl) - 3- ( 2- ( 2- hydroxypropan- 2- yl) phenyl) propylthio) methyl) cyclopropyl) acetic acid

    Clinical data

    Trade names Singulair

    AHFS/ Drugs. com monograph

    MedlinePlus a600014

    Pregnancy

    category

    AU: B1

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

    Legal status

    AU: Prescription Only ( S4)

    CA: ℞ - only

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability 63% to 73%

    Protein binding 99%

    Metabolism Hepatic ( CYP3A4 and CYP2C9- mediated)

    Biological half- life 2.7- 5.5 hours

    Excretion Biliary

    Identifiers

    CAS Registry Number 158966- 92- 8 Yes

    ATC code R03DC03

    PubChem CID: 5281040

    IUPHAR/ BPS 3340

    DrugBank DB00471 Yes

    ChemSpider 4444507 Yes

    UNII MHM278SD3E Yes

    KEGG D08229 Yes

    ChEBI CHEBI: 50730 Yes

    ChEMBL CHEMBL787 Yes

    Chemical data

    Formula C35H36ClNO3S

    Molecular mass 586.184 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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