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  • Bisoprolol Fumarate Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Bisoprolol Fumarate USP CAS No: 104344- 23- 2

    Batch No: BIS/ 030313 A. R. No 13/ FP/ BIS/ 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) Liquid Chromatography: 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.

    4. Related Substances

    Individual Impurity Total Impurity

    0.27 %

    0.31%

    NMT 0.5 %

    5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +1.1º Between –2° to +2°

    7. Water Content by KF 0.13% NMT 0.5%

    8. Content Of Fumaric Acid 15.1% 14.8- 15.4%

    10. Heavy Metals Complies NMT 20 ppm

    11. Residue On Ignition 0.04% NMT 0.1%

    12. Assay HPLC 98.58% 97.5 to 102.0%

    . .

    Bisoprolol

    Bisoprolol. svg

    Systematic ( IUPAC) name

    ( RS) - 1- { 4- [ ( 2- isopropoxyethoxy) methyl] phenoxy} -

    3- ( isopropylamino) propan- 2- ol

    Clinical data

    Trade names Concor

    AHFS/ Drugs. com monograph

    MedlinePlus a693024

    Licence data US FDA: link

    Pregnancy

    category

    AU: C

    US: C ( Risk not ruled out)

    Legal status

    ℞ ( Prescription only)

    Routes of

    administration oral

    Pharmacokinetic data

    Bioavailability >90%

    Protein binding 30% [ 1]

    Metabolism 50% Hepatic, CYP2D6, CYP3A4[ 2]

    Biological half- life 10–12 hours[ 3]

    Identifiers

    CAS Registry Number 66722- 44- 9 Yes

    ATC code C07AB07

    PubChem CID: 2405

    IUPHAR/ BPS 7129

    DrugBank DB00612 Yes

    ChemSpider 2312 Yes

    UNII Y41JS2NL6U Yes

    KEGG D02342 Yes

    ChEBI CHEBI: 3127 Yes

    ChEMBL CHEMBL645 Yes

    Chemical data

    Formula C18H31NO4

    Molecular mass 325.443 g/ mo


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 5, 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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