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Warfarin Sodium Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Warfarin Sodium USP CAS No: 129- 06- 6

Batch No: WAR/ 030313 A. R. No 13/ FP/ WAR/ 0303

Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

Batch Quantity 165 kg Date of Retest Jan- 2016

Sr. No Test Results Acceptance Criteria

1. Appearance

2. Solubility

3. Identification

Complies a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

Complies b) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

Complies c) Sodium: The filtrate obtained in Identification test A responds to the flame test for sodium.

4. Related Substances

Individual Impurity Total Impurity

0.12%

0.26%

NMT 0.3%

NMT 1.0%

5. pH 7.9 Between 7.2–8.3

6. Heavy Metals Complies NMT 10ppm

7. Water Content by KF 1.7% NMT 4.5%

8. Absorbance In Alkaline Solution 0.655 NMT 0.1

9. Assay HPLC 98.48% 97.0% –102.0%

Warfarin. svg

Warfarin ball- and- stick model. png

Systematic ( IUPAC) name

( RS) - 4- Hydroxy- 3- ( 3- oxo- 1- phenylbutyl) - 2H- chromen- 2- one

Clinical data

Trade names Coumadin, Jantoven, Marevan

AHFS/ Drugs. com monograph

MedlinePlus a682277

Licence data US FDA: link

Pregnancy

category

AU: D

US: X ( Contraindicated)

Legal status

AU: Prescription Only ( S4)

CA: ℞ - only

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration Oral or intravenous

Pharmacokinetic data

Bioavailability 79- 100% ( Oral) [ 1]

Protein binding 99% [ 2]

Metabolism Hepatic: CYP2C9, 2C19, 2C8, 2C18, 1A2 and 3A4[ 2]

Biological half- life 20- 60 hours ( mean: 40 hours) [ 2]

Excretion Renal ( 92% ) [ 2]

Identifiers

CAS Registry Number 81- 81- 2 YesI

ATC code B01AA03

PubChem CID: 54678486

IUPHAR/ BPS 6853

DrugBank DB00682

ChemSpider 10442445 Yes

UNII 5Q7ZVV76EI Yes

KEGG D08682 Yes

ChEBI CHEBI: 10033 Yes

ChEMBL CHEMBL1464

Chemical data

Formula C19H16O4

Molecular mass 308.33 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 14, 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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