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Apixaban Usp Ep Bpip Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Apixaban CAS No: 503612- 47- 3

Batch No: API/ 011114 A. R. No 14/ FP/ API/ 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 Complies

Complies The retention time of main peak of sample solution should be conformed with RT of main peak of standard solution

IR

3. Related substances

Impurity A

Impurity B

Single impurity

Total impurities

Not detected

0.065%

0.145%

NMT 0.35%

NMT 0.15%

NMT 0.1%

NMT 0.5%

4. Residual solvents

Methanol

Ethanol

Dichloromethane

Tetrahydrofuran

Ethyl acetate

Isopropyl alcohol

Ethylene glycol

0.02%

0.13%

Not detected

NMT 0.3%

NMT 0.06%

NMT 0.072%

NMT 0.62%

5. Loss on drying 0.42%

NMT 1.0%

6. Residue on ignition 0.059% NMT 0.1%

7. Heavy metals 20 PPM NMT 20 PPM

8. Assay 100.10% NLT 98.5%

.

Apixaban

Apixaban. svg

Apixaban ball- and- stick model. png

Systematic ( IUPAC) name

1- ( 4- methoxyphenyl) - 7- oxo- 6- [ 4- ( 2- oxopiperidin- 1- yl) phenyl] - 4, 5, 6, 7- tetrahydro- 1H- pyrazolo[ 3, 4- c] pyridine- 3- carboxamide

Clinical data

Trade names Eliquis

Licence data EMA: Link

Legal status

UK: Prescription- only ( POM)

Routes of

administration Oral

Pharmacokinetic data

Bioavailability ~50%

Protein binding ~87%

Metabolism CYP3A4, CYP3A5, CYP1A2 and others

Biological half- life 9–14 h

Excretion Biliary ( 75% ) , renal ( 25% )

Identifiers

CAS Registry Number 503612- 47- 3 Yes

ATC code B01AF02

PubChem CID: 10182969

IUPHAR/ BPS 6390

DrugBank DB07828 Yes

ChemSpider 8358471 Yes

UNII 3Z9Y7UWC1J Yes

KEGG D03213 Yes

ChEMBL CHEMBL231779 Yes

Chemical data

Formula C25H25N5O4

Molecular mass 459.497 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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