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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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