Impurity reference standards
Pitolisant impurities & reference standards
Characterised Pitolisant impurities, degradation products and related compounds for analytical method development, validation, QC release and regulatory filings.
17reference materials
COAHPLC · NMR · MS on request
Parent API: Pitolisant
362665-56-3 · C17H26ClNO
FAQs — Pitolisant impurities
Which Pitolisant impurities do you supply?
We list 17 Pitolisant-related reference materials, including process impurities, degradation products and related compounds. Each is supplied with a COA, and characterisation data (HPLC, 1H-NMR, MS, IR) can be provided on request.
What are Pitolisant impurity standards used for?
They are used for analytical method development and validation, impurity identification and quantification, forced-degradation and stability studies, and to support ANDA, DMF and other regulatory submissions under ICH Q3A/Q3B (and ICH M7 for mutagenic impurities).
Can you synthesise a Pitolisant impurity that is not listed?
Yes. Our custom synthesis service can prepare and characterise unlisted impurities, metabolites and labelled analogues from milligram to gram scale. Share the structure or name and required quantity for a quotation.
Request Pitolisant impurity standards
We reply within one business day with price, pack options, lead time and documentation.