Impurity reference standards
Pitolisant impurity standards
For Pitolisant, the Zemixal catalogue holds 12 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 metabolite or hydroxylated analogue.
12reference materials
1metabolites
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.
By impurity type
Metabolites1Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Pitolisant reference materials
1–12 of 12 standards
Questions
Pitolisant impurities, answered
What Pitolisant reference materials are available?
The catalogue currently lists 12 compounds for Pitolisant, including 1 metabolite or hydroxylated analogue. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Pitolisant impurity standard?
A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.
Can Zemixal make a Pitolisant impurity that is not listed?
Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.