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  • Bendamustine Hydrochloride Usp Ip Ep Bp Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Bendamustine hydrochloride CAS No:

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

    2. Solubility Complies Free soluble in methanol, water; insoluble in chloroform

    3. Identification Complies

    λ max1=232nm

    λ max2=330nm

    Complies Gives reaction of chloride

    IR: λ max1=233nm;

    λ max2=330nm;

    IR: comply with the spectrum of bendamustine HCL standard

    4. Appearance of solution Complies Clear and colorless

    5. PH 3.2 2.5 to 3.5

    6. Loss on drying 0.8% NMT 2.0%

    7. Heavy metals Complies NMT 20 PPM

    8. Assay 99.6% NLT 98.5%

    Bendamustine

    Bendamustine. png

    Systematic ( IUPAC) name

    4- [ 5- [ Bis( 2- chloroethyl) amino] - 1- methylbenzimidazol- 2- yl] butanoic acid

    Clinical data

    Trade names Treanda

    AHFS/ Drugs. com Consumer Drug Information

    MedlinePlus a608034

    Licence data US FDA: link

    Pregnancy

    category

    US: D ( Evidence of risk)

    Legal status

    US: ℞ - only

    Routes of

    administration Intravenous infusion

    Pharmacokinetic data

    Bioavailability NA ( intravenous only)

    Protein binding 94–96%

    Metabolism Hydrolyzed to inactive metabolites. Two minor metabolites ( M3 and M4) formed by CYP1A2

    Biological half- life 40 min ( bendamustine) , 3 h ( M3) , 30 min ( M4)

    Excretion ~50% urinary, ~25% fecal [ 1]

    Identifiers

    CAS Registry Number 16506- 27- 7 Yes

    ATC code L01AA09

    PubChem CID: 65628

    IUPHAR/ BPS 7478

    ChemSpider 59069 Yes

    UNII 9266D9P3PQ Yes

    ChEMBL CHEMBL487253 Yes

    Chemical data

    Formula C16H21Cl2N3O2

    Molecular mass 358.262 g/ mol


    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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