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  • Esomeprazole Magnesium Trihydrate Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name ESOMEPRAZOLE MAGNESIUM TRIHYDRATE CAS No:

    Batch No: ESO/ 011114 A. R. No 14/ FP/ ESO/ 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 slightly colored powder.

    2. Identification Complies

    Complies IR spectrum of sample should be

    concordant to that of Working

    standard of Esomeprazole magnesium.

    The test solution prepared and tested

    as directed in test for content of

    magnesium emission line at 285.1 nni

    3. Solubility Complies Soluble in methanol, slightly soluble

    in water. Practically in soluble

    in heptane.

    4. Colour of solution at 440 nm

    ( 20.0 mp ner mL in methanol) 0.11% NMT 0.2%

    5. Water 7.5% 6.0% to 8.0%

    6. Specific optical rotation ( o)

    ( 10.0 mg per mL in methanol

    at20oC\ - 138.9 - 137 to - 142

    7. Related substances

    By HPLC ( % )

    7.1 Omenrazole N- oxide

    7.2 Omeprazole sulfone

    ( Omeprazole related

    compound - A)

    7.3 individual impuritiy

    7.4 Total impurities Not detetcted

    0.07%

    0.03%

    0.12% NMT 0.1%

    NMT 0.2%

    NMT 0.1%

    NMT 0.5%

    . .

    Esomeprazole

    Esomeprazole 2D structure. svg

    Esomeprazole ball- and- stick model. png

    Systematic ( IUPAC) name

    ( S) - 5- Methoxy- 2- [ ( 4- methoxy- 3, 5- dimethylpyridin- 2- yl) methylsulfinyl] - 3H- benzoimidazole

    Clinical data

    Trade names Nexium, many others[ 1]

    AHFS/ Drugs. com monograph

    MedlinePlus a699054

    Licence data US FDA: link

    Pregnancy

    category

    AU: B3

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

    Legal status

    AU: Prescription Only ( S4)

    UK: General sales list ( GSL, OTC)

    US: Rx only IV OTC oral

    Routes of

    administration Oral, IV

    Pharmacokinetic data

    Bioavailability 50 to 90%

    Metabolism Hepatic ( CYP2C19, CYP3A4)

    Biological half- life 1–1.5 hours

    Excretion 80% Renal

    20% Faecal

    Identifiers

    CAS Registry Number 119141- 88- 7

    ATC code A02BC05

    PubChem CID: 9579578

    DrugBank DB00736 Yes

    ChemSpider 7843323

    UNII N3PA6559FT Yes

    KEGG D07917 Yes

    ChEBI CHEBI: 50275 Yes

    ChEMBL CHEMBL1201320

    Chemical data

    Formula C17H19N3O3S

    Molecular mass 345.417 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 8, 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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