Macitentan Related Compounds & Impurities

Macitentan is a dual endothelin ETA/ETB receptor antagonist with improved tissue penetration, used 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 Macitentan reference standards, pharmacopeial and non-pharmacopeial Macitentan 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 Macitentan-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

Macitentan
O-Desbromo-pyrimidinyl Macitentan
Macitentan Pyrimidine Amine Impurity
Despropylaminosulfonyl Macitentan
Macitentan Impurity 15
Macitentan Dimer Impurity
Macitentan Impurity 2
N-Despropyl-N-Ethyl Macitentan
Macitentan n-butyl analogue
Macitentan Impurity 14
Macitentan Impurity 4
Macitentan Isopropyl Impurity
N-Despropyl Macitentan
N-(5-(4-chlorophenyl)-6(2-((5-chloro-2pyridinyl)oxy)ethoxy) 4-pyrimidinyl)-N'-propylsulfamide
Macitentan 4-Chloro Analog
Macitentan Impurity H
N-Nitroso Macitentan
N-nitroso N-Propyl Sulfamide
Macitentan Impurity 25
Macitentan Impurity 17
Macitentan Stage-I Hydroxy Impurity
5-(3-Bromophenyl)-4,6-dichloropyrimidine
5-(2-Bromophenyl)-4,6-dichloropyrimidine
5-(4-bromophenyl)-6-chloropyrimidin-4-ol
N-Nitroso Macitentan Dimer Impurity
S-Despropylamino S-Methyl Macitentan
N-Despropyl-N-Methyl Macitentan
5-desbromo-5-Chloro Macitentan
N-Nitroso Pyrimidine Amine Impurity
Macitentan Nitroso Pyrimidine N-Propyl Impurity
N-Boc-sulfamoyl Chloride
5-Des-Bromo-Macitentan
Macitentan Impurity 3
N-Nitroso Macitentan Impurity 1
Macitentan Impurity 5
Macitentan Impurity 6
Macitentan Impurity 7
Macitentan Impurity 8
Macitentan Impurity 9
Macitentan Impurity 10
N-Nitroso Macitentan Hydroxy N-Propyl Impurity
Macitentan Impurity 11
Macitentan Impurity 1
Macitentan Impurity 12
Macitentan Impurity 13
Macitentan Impurity 16

Metabolites

N-Despropyl Macitentan
Macitentan ACT-373898
Macitentan Metabolite M7

Isotope Labelled Compounds

Macitentan D4
N-Despropyl Macitentan-D4
[13C2, 2H4]-Macitentan Metabolite
Macitentan 13C2 D4