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Impurity reference standards

Etilefrine impurity standards

For Etilefrine, the Zemixal catalogue holds 8 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 pharmacopoeial impurity and 2 metabolites or hydroxylated analogues.

8reference materials
1pharmacopoeial
2metabolites

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

Pharmacopoeial1EP, USP, BP or JP named impurities
Metabolites2Hydroxy, desmethyl and conjugated forms

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

All Etilefrine reference materials

Questions

Etilefrine impurities, answered

What Etilefrine reference materials are available?
The catalogue currently lists 8 compounds for Etilefrine, including 1 pharmacopoeial impurity and 2 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 Etilefrine 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 Etilefrine 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.
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