Irbesartan Related Compounds & Impurities

Irbesartan is an angiotensin II AT1 receptor blocker used for hypertension and diabetic nephropathy renal protection.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Irbesartan reference standards, pharmacopeial and non-pharmacopeial Irbesartan impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Irbesartan-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Irbesartan
Irbesartan
Irbesartan EP Impurity A
2-Butyl-1,3-diazaspiro[4.4]non-1-ene-4-one hydrochloride
Monobutyltin
Tetrabutylstannane
Irbesartan N1 Trityl Impurity
Irbesartan Impurity B
Irbesartan Impurity C
Irbesartan Impurity D
Irbesartan Propyl Analogue
Irbesartan Dimethyl Impurity
Irbesartan Propyl Analogue
Irbesartan EP impurity A
Irbesartan Lactam Impurity
4-(2-butyl-4-oxo-1,3-diazaspiro(4,4)non-1-en-3-yl)methylbiphenyl-2-carbonitrile hydrochloride
Cycloleucine
N-Triphenylmethyl Irbesartan
Irbesartan Dimer Impurity
Irbesartan Form A
1-Amino-1-cyanocyclopentane Hydrochloride
Irbesartan Bromo IBE Impurity
Irbesartan Impurity 1
Irbesartan Carboxamide
Irbesartan Cyano Impurity Hydrochloride
Irbesartan Form B
Irbesartan Impurity 12
Irbesartan USP Related Compound A
Demethyl Irbesartan
Nitroso Irbesartan
Nitroso Spiro Irbesartan
Irbesartan Nitroso Impurity 1
Irbesartan Impurity 5
Irbesartan Impurity 8
Irbesartan Impurity 20
Irbesartan Form B(Crystalline form)
Irbesartan Impurity 3
(R)-methyl2-(((2`-cyano-[1,1`-biphenyl]-4-yl)methyl)(nitroso)amino)-3-methylbutanoate oxalate
5-[4'-(Bromomethyl)[1,1'-biphenyl]-2-yl]-2H-tetrazole
5-(4'-(Dibromomethyl)-[1,1'-biphenyl]-2-yl)-1H-tetrazole
4~-(hydroxymethyl)-[1,1~-biphenyl]-2-carboxylic acid
Irbesartan Impurity 18
(R)-methyl-2-(((2`-cyano-[1,1`-biphenyl]-4-yl)methyl)(nitroso)amino)-3-methylbutanoate
Irbesartan Impurity 7
Valsartan Impurity 30
Irbesartan Impurity 19
Irbesartan Impurity 23
Irbesartan Impurity 4
Irbesartan Impurity 6
Irbesartan Impurity 2

Metabolites

Irbesartan N-beta-D-Glucuronide

Isotope Labelled Compounds

Irbesartan-d3
Irbesartan-d7
Irbesartan D4
Irbesartan Impurity 15-D4 Sodium Salt
5-[4`-(Azidomethyl)[1,1`-biphenyl]-2-yl]-2H-tetrazole-D4
Irbesartan Impurity 14-D4
Irbesartan-13C-D4