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Impurity reference standards

Omeprazole impurity standards

49 characterised compounds linked to Omeprazole are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 5 pharmacopoeial impurities, 2 isotope-labelled standards, 8 metabolites or hydroxylated analogues and 2 degradation products.

49reference materials
5pharmacopoeial
2isotope labelled
8metabolites
Omeprazole structure
Parent API

Omeprazole

CAS
73590-58-6
Formula
C17H19N3O3S
MW
345.4 g/mol
Code
ZX-004202

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

Pharmacopoeial5EP, USP, BP or JP named impurities
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites8Hydroxy, desmethyl and conjugated forms
Degradants2N-oxides, dimers, lactones and breakdown products

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

All Omeprazole reference materials

1–49 of 49 standards
Questions

Omeprazole impurities, answered

How many Omeprazole impurity standards does Zemixal list?
The catalogue currently lists 49 compounds for Omeprazole, including 5 pharmacopoeial impurities, 2 isotope-labelled standards, 8 metabolites or hydroxylated analogues and 2 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Omeprazole 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 Omeprazole 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 Omeprazole standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.
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