Bosentan hydrate Related Compounds & Impurities

Bosentan Hydrate is an oral dual endothelin-A/B receptor antagonist that reduces pulmonary vascular resistance, used as a foundational therapy for pulmonary arterial hypertension.

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 Bosentan hydrate reference standards, pharmacopeial and non-pharmacopeial Bosentan hydrate 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 Bosentan hydrate-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

Bosentan Monohydrate
O-Deshydroxyethyl Bosentan
Bosentan USP Related Compound A
Bosentan Chlorosulfonamide Cesium Salt
Bosentan USP Related Compound D
Bosentan Dimer Impurity
Bosentan USP Related Compound E
Bosentan Monohydrate Ethyl Ester Impurity
N,N'-[5-(2-methoxyphenoxy)[2,2'-bipyrimidine]-4,6-diyl]bis[4-(1,1-dimethylethyl)benzenesulfonamide]
O-Desmethyl Bosentan
Bosentan Impurity 9
Bosentan hydroxyethoxy Ethyl
4-(tert-butyl)-N-((tertbutyl)phenyl)sulfonyl)benzenesulfonamide
2-Methyl-2-phenylpropanoic acid
Bosentan Impurity 5
Bosentan Impurity 3
Bosentan Impurity 4
4-tert-butylbenzenesulfonic acid
Bosentan Related Compound B
Bosentan Related Compound 4
4-tert-butyl-N-[6-ethoxy-5-(2-methoxyphenoxy)-[2,2`-bipyrimidin]-4-yl]benzene-1-sulfonamide
Bosentan Impurity 6
Bosentan Chloro Impurity
Bosentan Impurity 1
Bosentan Impurity 2
Bosentan Impurity 7
Bosentan Impurity 8
Bosentan Impurity 10
Bosentan Impurity 11
Bosentan Impurity 12
Bosentan Impurity 13
Bosentan Impurity 14
Bosentan Impurity 15
Bosentan Impurity 16
Bosentan Impurity 17

Isotope Labelled Compounds

Bosentan-D4
Bosentan 13C6