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  • Lapatinib Base Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name LAPATINIB BASE CAS No:

    Batch No: LAP/ 011114 A. R. No 14/ FP/ LAP/ 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 Yellow powder

    2. Identification Complies IR

    3. Melting point 143.5ºC to 144.9℃ 141ºC to 149ºC

    4. Loss on drying 0.5% NMT 1.0

    5. Heavy metals Complies NMT 20 PPM

    6. Purity 99.34% NLT 99.0%

    . .

    Lapatinib

    Lapatinib2DACS. svg

    Lapatinib3Dan. gif

    Systematic ( IUPAC) name

    N- [ 3- chloro- 4- [ ( 3- fluorophenyl) methoxy] phenyl] - 6-

    [ 5- [ ( 2- methylsulfonylethylamino) methyl] - 2- furyl]

    quinazolin- 4- amine

    Clinical data

    Trade names Tykerb, Tyverb

    AHFS/ Drugs. com monograph

    MedlinePlus a607055

    Licence data EMA: Link, US FDA: link

    Pregnancy

    category

    AU: D

    US: D ( Evidence of risk)

    D

    Legal status

    AU: Prescription Only ( S4)

    CA: ℞ - only

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability Variable, increased with food

    Protein binding >99%

    Metabolism Hepatic, mostly CYP3A- mediated ( minor 2C19 and 2C8 involvement)

    Biological half- life 24 hours

    Excretion Mostly fecal

    Identifiers

    CAS Registry Number 231277- 92- 2

    388082- 78- 8 ( ditosylate)

    ATC code L01XE07

    PubChem CID: 208908

    IUPHAR/ BPS 5692

    DrugBank DB01259 Yes

    ChemSpider 181006 Yes

    UNII 0VUA21238F Yes

    KEGG D04024

    ChEBI CHEBI: 49603 Yes

    ChEMBL CHEMBL554 Yes

    Chemical data

    Formula C29H26ClFN4O4S

    Molecular mass 581.058 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 9, 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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