Ambrisentan Related Compounds & Impurities

Ambrisentan is a selective endothelin type-A 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 Ambrisentan reference standards, pharmacopeial and non-pharmacopeial Ambrisentan 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 Ambrisentan-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

Ambrisentan
Ambrisentan R isomer
Ambrisentan Vinyloxy Impurity
Ambrisentan Hydroxy Acid Impurity (S-isomer)
Ambrisentan Hydroxy Acid Impurity (R-Isomer)
Ambrisentan Hydroxyester Impurity
Ambrisentan Sulfonyl Pyrimidine Impurity
4,6-Dimethyl-2-hydroxypyrimidine
Ambrisentan Methyl Ester
Ambrisentan Acyl Beta-D-Glucuronide
Ambrisentan N-oxide
4-Hydroxymethyl ambrisentan acyl beta-glucuronide
Ambrisentan Impurity 6
(S)-methyl-2-hydroxy-3-methoxy-3,3-diphenylpropanoate
Ambrisentan Epoxide
Ambrisentan Impurity 1
Ambrisentan Impurity E
Ambrisentan Ethyl Ester
Ambrisentan Methyl Ester Racemate
Ambrisentan Pyrimidine Ester Impurity
Rac O-Demethyl Ambrisentan
Ambrisentan Acyl Glucuronide (Mixture of Diastereomers)

Metabolites

Ambrisentan 4-Hydroxymethyl Analog Racemate
4-hydroxymethyl ambrisentan

Isotope Labelled Compounds

Ambrisentan D3
Ambrisentan-D10
Rac-Ambrisentan-D5