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Imatinib Base Usp Ip Bp Ep Manufacturer - India

price: contact company for price

Imatinib

Imatinib2DACS. svg

Ball- and- stick model of the imatinib molecule

Systematic ( IUPAC) name

4- [ ( 4- methylpiperazin- 1- yl) methyl] - N- ( 4- methyl- 3- { [ 4- ( pyridin- 3- yl) pyrimidin- 2- yl] amino} phenyl) benzamide

Clinical data

Trade names Gleevec, Glivec

AHFS/ Drugs. com monograph

MedlinePlus a606018

Licence data EMA: Link, US FDA: link

Pregnancy

category

AU: D

US: D ( Evidence of risk)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 98%

Protein binding 95%

Metabolism Hepatic ( mainly CYP3A4- mediated)

Biological half- life 18 hours ( imatinib)

40 hours ( active metabolite)

Excretion Fecal ( 68% ) and renal ( 13% )

Identifiers

CAS Registry Number 152459- 95- 5 Yes

220127- 57- 1 ( mesilate)

ATC code L01XE01

PubChem CID: 5291

IUPHAR/ BPS 5687

DrugBank DB00619 Yes

ChemSpider 5101 Yes

UNII BKJ8M8G5HI Yes

KEGG D08066 Yes

ChEBI CHEBI: 45783 Yes

ChEMBL CHEMBL941 Yes

Chemical data

Formula C29H31N7O

Molecular mass 493.603 g/ mol

589.7 g/ mol ( mesilate)

CERTIFICATE OF ANALYSIS

Product Name Imatinib Base CAS No: 152459- 95- 5

Batch No: IMA/ 011114 A. R. No 14/ FP/ IMA/ 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 Pale yellow to white

crystalline powder

2. Identification Complies H- NMR, MS

3. Melting point 207.5ºC to 208.5ºC 207ºC to 209ºC

4. Loss on drying 0.09% NMT 1.0%

5. Residue on ignition 0.03% NMT 0.1%

6. Related impurity 0.33% Total impurities NMT 1.0%

7. Purity 99.67% NLT 99.0%


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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