Darifenacin Related Compounds & Impurities

Darifenacin is a selective muscarinic M3 receptor antagonist that preferentially reduces detrusor muscle contractility with reduced salivary-gland side effects, used for overactive bladder syndrome.

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 Darifenacin reference standards, pharmacopeial and non-pharmacopeial Darifenacin 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 Darifenacin-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

Darifenacin
Darifenacin Pyrrolidine Impurity (S)-Isomer
Darifenacin Impurity B
Darifenacin Impurity C
Darifenacin Impurity C Hydrobromide salt
Darifenacin Racemic Mixture Hydrobromide Salt
Darifenacin R Isomer
Darifenacin S Isomer
Darifenacin N-Oxide
Darifenacin Impurity D
Darifenacin Impurity D
Darifenacin KSM-II B(1-tosyl-(3S)-hydrox
Darifenacin KSM-II C (1-tosyl-(3S)-tosyl)
Darifenacin Oxidized Impurity
Darifenacin Oxidized Impurity Hydrobromide
Diphenylacetonitrile
Darifenacin Nitrile Impurity
Darifenacin Impurity A
Darifenacin EP Impurity A Hydrobromide
Darifenacin Impurity C
Darifenacin 3-Hydroxy Impurity
Darifenacin 5-Carboxymethyl Impurity
Darifenacin EP Impurity H
Darifenacin Dimer-2 Impurity
Darifenacin Dimer-2 Impurity Hydrochloride salt
7-Bromo Darifenacin
2-(2,3-dihydrobenzofuran-7-yl)acetic acid
Darifenacin Pyrrolidine Impurity Racemate
5-(2-Bromoethyl)benzofuran
Darifenacin Vinylbenzofuran Impurity
(S)-2,2-diphenyl-2-(pyrrolidin-3-yl)acetic acid
3-cyanodiphenyl-methyl-1-2-2-3-dihydrobenzofuran-5-yl-ethyl-pyrrolidine-hydrobromide
Darifenacin 7-Bromoethyl Impurity
Darifenacin Carboxylic Acid Impurity
Darifenacin Bromo Impurity
2-(2,3-dihydro-1-benzofuran-5-yl)ethanol
Darifenacin Impurity 5
2-Oxodarifenacin
Darifenacin 4-Hydroxy Impurity
Darifenacin Impurity 7
Darifenacin R-Isomer
Darifenacin Vinyl Impurity
Darifinacin Bromophenol Impurity
Darifenacin Pyrrolidinium Dimer Impurity
3-Hydroxy Darifenacin (Mixture of Diastereomers)
(3S)-1-Tosyl-,-diphenyl-3-pyrrolidineacetonitrile
Darifenacin Impurity 9
Darifenacin 4-Hydroxy Impurity Hydrobromide
(S)-2,2-Diphenyl-2-(pyrrolidin-3-yl)acetonitrile
2,3-Dihydro-5-Vinylbenzofuran
Darifenacin Hydrobromide
Darifenacin Impurity 11
2-(1-{2-[3-(2-sec-butoxy-ethyl)-4-hydroxy-phenyl]-ethyl}-pyrrolidin-3-yl)-2,2-diphenyl-acetamide
Darifenacin EP Impurity E
2-Hydroxy-4-amino Butanoic Acid
Darifenacin Dimer-1 Impurity
Darifenacin Impurity F
3-(S)-(+)-(1-carbamoyl-1,1-diphenyl methyl)pyrrolidine
(R)-2,2-diphenyl-2-(pyrrolidin-3-yl)acetamide 2,3-dihydroxysuccinate
3-(1-cyano-1,1-diphenyl)methyl-1-tosyl pyrrolidine
Darifenacin cyano Impurity
Darifenacin Nitroso Impurity 1
(S)-1-Nitrosopyrrolidin-3-ol
Darifenacin Cyano Pyrrolidine Nitroso Impurity
Darifenacin Impurity 15
Darifenacin Amide Nitroso Impurity
Darifenacin Impurity 2

Isotope Labelled Compounds

Darifenacin-D4