Ketotifen Fumarate Related Compounds & Impurities

Ketotifen Fumarate is a non-competitive H1-antihistamine and mast cell stabiliser used for allergic asthma prophylaxis and allergic conjunctivitis.

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 Ketotifen Fumarate reference standards, pharmacopeial and non-pharmacopeial Ketotifen Fumarate 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 Ketotifen Fumarate-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

Ketotifen Fumarate
Ketotifen
Ketotifen Fumarate EP Impurity A
Ketotifen Fumarate EP Impurity B
Ketotifen Fumarate EP Impurity C
Ketotifen Fumarate EP Impurity D
Ketotifen Fumarate EP Impurity E
Ketotifen Fumarate EP Impurity F
Ketotifen Fumarate EP Impurity G
Ketotifen-D3 Fumarate
9,10-Dihydro-4H-benzo[4,5]cyclohepta[1,2-b]thiophen-4-one
Norketotifen
Ketotifen Fumarate EP Impurity F Hemifumarate
Ketotifen Impurity 3
Ketotifen Impurity 1
Ketotifen Impurity 9
Norketotifen Hydrogen Fumarate
Ketotifen Impurity 9
Ketotifen Impurity 10
Ketotifen Impurity 14
Ketotifen Impurity 15
Ketotifen Impurity 16
Ketotifen Impurity 11
Ketotifen Related Compound G
Ketotifen Impurity 2
N-Nitroso N-Desmethyl Ketotifen
Ketotifen Fumarate EP Impurity E Fumarate

Metabolites

Norketotifen Hydrochloride

Isotope Labelled Compounds

Norketotifen D4