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  • Clopidogrel Bisulphate Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name CLOPIDOGREL BISULPHATE CAS No:

    Batch No: CLO/ 011114 A. R. No 14/ FP/ CLO/ 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 or off- white powder

    2. Identification Complies

    Complies

    Complies IR : An IR spectrum of sample is

    concordant with IR spectrum of

    Clopidogrel Bisulphate Form- II

    working standard.

    HPLC : The retention time of the major peak in

    the chromatogram of the Assay

    preparation corresponds to that in the

    chromatogram of the Clopidogrel

    Bisulphate Form- II Standard

    preparation as obtained in the assay.

    By sulphates

    3. Solubility Complies Freely soluble in methanol

    4. Loss on drying 0.34% NMT 0.50%

    5. Related Compounds by HPLC

    Compound A

    Compound B

    Compound C

    Other impurity

    Total impurities

    0.17%

    0.21%

    0.75%

    0.06%

    1.20%

    NMT 0.20%

    NMT 0.30%

    NMT 1.00%

    NMT 0.10%

    NMT 1.50%

    6. Residue on ignition 0.07% NMT 0.10%

    7. Assay 99.70% 97.0% to 101.5%

    .

    Clopidogrel

    Clopidogrel skeletal formula. svg

    Clopidogrel ball- and- stick model. png

    Systematic ( IUPAC) name

    ( +) - ( S) - methyl 2- ( 2- chlorophenyl) - 2- ( 6, 7- dihydrothieno[ 3, 2- c] pyridin- 5( 4H) - yl) acetate

    Clinical data

    Trade names Plavix

    AHFS/ Drugs. com monograph

    MedlinePlus a601040

    Licence data US FDA: link

    Pregnancy

    category

    AU: B1

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

    Legal status

    AU: Prescription Only ( S4)

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability >50%

    Protein binding 94–98%

    Metabolism Hepatic

    Biological half- life 7–8 hours ( inactive metabolite)

    Excretion 50% renal

    46% biliary

    Identifiers

    CAS Registry Number 113665- 84- 2 Yes

    ATC code B01AC04

    PubChem CID: 60606

    IUPHAR/ BPS 7150

    DrugBank DB00758 Yes

    ChemSpider 54632 Yes

    UNII A74586SNO7 Yes

    KEGG D07729 Yes

    ChEBI CHEBI: 37941 Yes

    ChEMBL CHEMBL1771 Yes

    Chemical data

    Formula C16H16ClNO2S

    Molecular mass 321.82 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 6, 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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