Bilastine Related Compounds & Impurities

Bilastine is a second-generation non-sedating H1-receptor antihistamine with rapid onset, used for allergic rhinoconjunctivitis and urticaria.

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 Bilastine reference standards, pharmacopeial and non-pharmacopeial Bilastine 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 Bilastine-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

Bilastine
1`-Hydroxy Bilastine
Bilastine N-Oxide
Bilastine Impurity 17
Bilastine Hydroxy Impurity
Bilastine Impurity 27
Bilastine Impurity 23
Bilastine Impurity 4
Bilastine Impurity 5
Bilastine Impurity 12
Bilastine Impurity 25
Bilastine Impurity 6
Bilastine Impurity 1
Bilastine Impurity 2
Bilastine Impurity 29
Bilastine Impurity A
Bilastine Impurity B
Bilastine Amide Impurity
Bilastine Impurity 13
Bilastine Nitroso Impurity 1
Bilastine-N-Nitrosoamine Impurity-1
Bilastine Propanamide Impurity
Bilastine Chloro Impurity
Bilastine Impurity 30
1-(2-Ethoxy-ethyl)-2-piperidin-4-yl-1H-benzimidazole,Hydrochloride Sesquihydrate
Bilastine Impurity 15
Bilastine Impurity 16
Bilastine Impurity 19
Bilastine Impurity 20
Bilastine Impurity 21
Bilastine Impurity 22
2-Methyl-2-(p-tolyl)propanoic Acid
Bilastine Impurity 7
cis-Bilastine N-Oxide
2-(Piperidin-4-yl)-1H-benzo[d]imidazole Hydrate
2-[4-(2-bromoacetyl)phenyl]-2-methylpropanoic acid
2-[4-(2-bromoethyl)phenyl]-2-methylpropanoic acid
Methyl,Alpha,Alpha-dimethyl-4-[2-[[(4-methylphenyl)sulfonyl]oxy]ethyl]benzeneacetate
trans-Bilastine N-Oxide
Bilastine Impurity 11
Bilastine Impurity 28
Bilastine Nitroso Impurity 2
2-Desetoxyethyl-4,5-Dihydrooxazole Bilastine
Bilastine Keto Impurity
Bilastine Impurity 11 Hydrochloride Salt
Desethoxy Ethyl Bilastine Impurity
Bilastine Impurity 33
Bilastine Impurity 34
Bilastine Impurity 6 Hydrochloride
Bilastine Impurity 35
Bilastine Impurity 36
Bilastine Impurity 27 Hydrochloride
Bilastine form III
Methyl2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)-1-hydroxyethyl)phenyl)-2-methylpropanoate
Tert-butyl4-(1-nitroso-1H-benzo[d]imidazol-2-yl)piperidine-1- carboxylate
Bilastine Impurity 37
Bilastine Impurity 38
Bilastine Butyl Ester Impurity
Bilastine Impurity 39
Bilastine Hydroxy Impurity Hydrochloride
3-Oxabutyl tosylate
3,6-Dioxaoctyl tosylate
Pentyl tosylate
Bilastine Impurity 40
Bilastine Impurity 42
Bilastine Impurity 43
Bilastine Impurity 44
Bilastine Nitroso Impurity 3
Bilastine Impurity 45
Bilastine Form I
Bilastine Impurity 47 Hydrochloride
Bilastine Impurity 8
Bilastine Nitroso Impurity 4
Bilastine Nitroso Impurity 5
Bilastine Impurity 10
Bilastine Impurity 9
Bilastine Impurity 14
Bilastine Impurity 18
Bilastine Impurity 24
Bilastine Form II
Bilastine Impurity 3

Isotope Labelled Compounds

Bilastine D6
Bilastine-D4