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Febuxostat Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name FEBUXOSTAT CAS No:

Batch No: FEB/ 011114 A. R. No 14/ FP/ FEB/ 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 almost wlir. teeoloredpowder

2. Identification( by HPLC) Complies The sample spectrum should

matches with major functional

groups.

3. Solubility Complies Freely soluble in DMF and

practicallv insoluble in water

4. Loss on drying 0.20% NMT 1.0%

5. Sulphated ash 0.06% NMT 0.10%

6. Heavy metals Complies NMT 20 PPM

7. Related substances

Single impurity

Total impurities

0.12%

0.19%

NMT 0.50%

NMT 1.0%

8. Residual solvents

a) Methanol

b) Ethanol

c) Dichloromethane

d) Acetone

e) Dimethyl formamaide

f) Toluene

3 PPM

5PPM

Not detected

3 PPM

NMT 3000 PPM

NMT 5000 PPM

NMT 600 PPM

NMT 880 PPM

NMT 890 PPM

.

Febuxostat

Febuxostat. svg

Systematic ( IUPAC) name

2- ( 3- cyano- 4- isobutoxyphenyl) - 4- methyl-

1, 3- thiazole- 5- carboxylic acid

Clinical data

Trade names Uloric, Adenuric, Atenurix, feburic. Generic in several countries. [ 1]

AHFS/ Drugs. com monograph

MedlinePlus a609020

Licence data EMA: Link, US FDA: link

Pregnancy

category

US: C ( Risk not ruled out)

Legal status

US: ℞ - only

Routes of

administration Oral

Pharmacokinetic data

Bioavailability ~49% absorbed

Protein binding ~99% to albumin

Metabolism via CYP1A2, 2C8, 2C9, UGT1A1, 1A3, 1A9, 2B7

Biological half- life ~5- 8 hours

Excretion Urine ( ~49% mostly as metabolites, 3% as unchanged drug) ; feces ( ~45% mostly as metabolites, 12% as unchanged drug)

Identifiers

CAS Registry Number 144060- 53- 7

ATC code M04AA03

PubChem CID: 134018

IUPHAR/ BPS 6817

ChemSpider 118173 Yes

UNII 101V0R1N2E Yes

KEGG D01206 Yes

ChEMBL CHEMBL1164729 Yes

Chemical data

Formula C16H16N2O3S

Molecular mass 316.374 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 8, 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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