Ivacaftor Related Compounds & Impurities

Ivacaftor is a CFTR potentiator that enhances chloride channel gating in specific CFTR mutations, used for cystic fibrosis.

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 Ivacaftor reference standards, pharmacopeial and non-pharmacopeial Ivacaftor 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 Ivacaftor-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

Ivacaftor Ethyl Ester Impurity
Ivacaftor Acid Impurity
Ivacaftor
Hydroxymethyl Ivacaftor
Ivacaftor Carboxylic Acid
Ivacaftor Amine Impurity
6-Amino-2,4-di-tert-butylphenol
Ivacaftor Ortho Isomer
N-Nitroso Ivacaftor
N-Nitroso Ivacaftor Ortho Isomer
N-Nitroso Quinoline Acid
N-Nitroso De-alkylated Ivacaftor
Ivacaftor Impurity 4
De-Alkylated Ivacaftor
Ivacaftor Nitroso Impurity 5
Ivacaftor Nitroso Impurity 2
Ivacaftor Nitroso Impurity 4
Ivacaftor O-beta-D-glucuronide
Ivacaftor Impurity 16
Ivacaftor Nitroso Impurity 6
4-Hydroxyquinoline-3-carboxylic acid
Ivacaftor Impurity 8
Ivacaftor Impurity 19
Ivacaftor Impurity 11
Ivacaftor Impurity 1
Ivacaftor Impurity 21
Ivacaftor Impurity 22
Ivacaftor Impurity 23
Ivacaftor Impurity 24
Ivacaftor Impurity 25
Ivacaftor Impurity 26
Ivacaftor Impurity 27
Ivacaftor Impurity 28
Ivacaftor Impurity 29
Ivacaftor N-Glucuronide
Ivacaftor Impurity 30
Ivacaftor Impurity 20
Ivacaftor Impurity 31
Ivacaftor Impurity 32
Ivacaftor Impurity 33
Ivacaftor Impurity 5
Ivacaftor Impurity 2
Ivacaftor Impurity 3
Ivacaftor Nitro phenol Impurity

Isotope Labelled Compounds

Ivacaftor-d18
Ivacaftor D4
Ivacaftor D19
Ivacaftor 13C6
Hydroxymethyl Ivacaftor D6
Deutivacaftor