Bepotastine Related Compounds & Impurities

Bepotastine is a second-generation H1-receptor antihistamine used for allergic rhinitis, conjunctivitis and pruritus.

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 Bepotastine reference standards, pharmacopeial and non-pharmacopeial Bepotastine 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 Bepotastine-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

Bepotastine Besylate
Bepotastine
Bepotastine Salicylate
Bepotastine Impurity A Tartrate
Bepotastine Ethyl Ester Fumarate
Bepotastine Impurity 1(S-isomer)
Bepotastine impurity 1(R-isomer)
Bepotastine Ethyl Ester
(R)-Bepotastine Besylate
(R)-Bepotastine
Bepotastine Besylate Racemic Mixture
Bepotastine Isopropyl Ester Impurity
Bepotastine n-Butyl Ester Impurity
Bepotastine N-Oxide
(S)-4-(4-(phenyl(pyridin-2-yl)methoxy)piperidin-1-yl)butanoic acid
Racemic Bepotastine
Bepotastine Impurity 8
Bepotastine Impurity 2
Bepotastine Impurity 3

Isotope Labelled Compounds

Bepotastine-D6 Besylate