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Impurity reference standards

Propofol impurity standards

For Propofol, the Zemixal catalogue holds 24 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 14 pharmacopoeial impurities, 1 isotope-labelled standard and 4 metabolites or hydroxylated analogues.

24reference materials
14pharmacopoeial
1isotope labelled
4metabolites

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

Pharmacopoeial14EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites4Hydroxy, desmethyl and conjugated forms

Counts are based on product names. One compound can fall into more than one type.

All Propofol reference materials

1–24 of 24 standards
Questions

Propofol impurities, answered

What Propofol reference materials are available?
The catalogue currently lists 24 compounds for Propofol, including 14 pharmacopoeial impurities, 1 isotope-labelled standard and 4 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Propofol 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 Propofol 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.
Are isotope-labelled Propofol standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.
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