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Axitinib Usp Ep Ip Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Axitinib CAS No:

Batch No: ATR/ 011114 A. R. No 14/ FP/ ATR/ 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. Identification

IR

HPLC

Complies

Complies

IR chromatograph Conforms to the characteristic peak of R. S.

The retention time of the major peak in the chromatogram Conforms to the characteristic peak of R. S.

3. Residue on ignition 0.08% NMT 0.20%

4. Related substances

Total impurities

Single impurity

0.16%

0.04%

NMT 1.0%

NMT 0.50%

5. Loss on drying 0.10% NMT 1.0%

6. Heavy metals Complies NMT 20 PPM

7. Purity 100.0% NLT 99.0%

.

Axitinib

Axitinib2DACS. svg

Axitinib3Dan. gif

Systematic ( IUPAC) name

N- Methyl- 2- [ [ 3- [ ( E) - 2- pyridin- 2- ylethenyl] - 1H- indazol- 6- yl] sulfanyl] benzamide

Clinical data

Trade names Inlyta

AHFS/ Drugs. com monograph

MedlinePlus a612017

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 58% [ 1]

Protein binding >99% [ 1]

Metabolism Hepatic ( mostly CYP3A4/ CYP3A5- mediated but with some contributions from CYP1A2, CYP2C19, UGT1A1) [ 1]

Biological half- life 2.5- 6.1 hours[ 1]

Excretion Faeces ( 41% ; 12% as unchanged drug) , urine ( 23% ) [ 1]

Identifiers

CAS Registry Number 319460- 85- 0 Yes

ATC code L01XE17

PubChem CID: 6450551

IUPHAR/ BPS 5659

ChemSpider 4953153 Yes

UNII C9LVQ0YUXG Yes

KEGG D03218 Yes

ChEBI CHEBI: 66910

ChEMBL CHEMBL1289926

PDB ligand ID AXI ( PDBe, RCSB PDB)

Chemical data

Formula C22H18N4OS

Molecular mass 386.469 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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