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Irbesartan Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Irbesartan USP CAS No: 138402- 11- 6

Batch No: IRB/ 030313 A. R. No 13/ FP/ IRB/ 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.

4. Related Substances

Individual Impurity Total Impurity

0.052%

0.21%

NMT 0.1%

NMT 0.5%

5. Heavy Metals Complies 20ppm

6. Water Content by KF 0.17% NMT 0.5%

7. Residue On Ignition 0.064% NMT 0.1%

8. Assay HPLC 98.76% 98.0% –102.0%

. .

Irbesartan

Irbesartan skeletal. svg

Systematic ( IUPAC) name

2- butyl- 3- ( { 4- [ 2- ( 2H- 1, 2, 3, 4- tetrazol- 5- yl) phenyl] phenyl} methyl) - 1, 3- diazaspiro[ 4.4] non- 1- en- 4- one

Clinical data

Trade names Avapro

AHFS/ Drugs. com monograph

MedlinePlus a698009

Licence data EMA: Link, US FDA: link

Pregnancy

category

D ( Au)

Legal status

S4 ( Au) , POM ( UK) , ℞ - only ( U. S. )

Routes of

administration Oral

Pharmacokinetic data

Bioavailability 60–80%

Protein binding ~90%

Metabolism Hepatic ( CYP2C9)

Biological half- life 11–15 hours

Excretion Renal 20% , faecal 65%

Identifiers

CAS Registry Number 138402- 11- 6 Yes

ATC code C09CA04

PubChem CID: 3749

IUPHAR/ BPS 589

DrugBank DB01029 Yes

ChemSpider 3618 Yes

UNII J0E2756Z7N Yes

KEGG D00523 Yes

ChEBI CHEBI: 5959 Yes

ChEMBL CHEMBL1513 Yes

Chemical data

Formula C25H28N6O

Molecular mass 428.53 g/ mol


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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