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Impurity reference standards

Naltrexone impurity standards

28 characterised compounds linked to Naltrexone are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 9 pharmacopoeial impurities, 1 isotope-labelled standard, 4 metabolites or hydroxylated analogues and 1 degradation product.

28reference materials
9pharmacopoeial
1isotope labelled
4metabolites
Naltrexone structure
Parent API

Naltrexone

CAS
16590-41-3
Formula
C20H23NO4
MW
341.4 g/mol
Code
ZX-006669

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Pharmacopoeial9EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites4Hydroxy, desmethyl and conjugated forms
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Naltrexone reference materials

1–28 of 28 standards
Questions

Naltrexone impurities, answered

How many Naltrexone impurity standards does Zemixal list?
The catalogue currently lists 28 compounds for Naltrexone, including 9 pharmacopoeial impurities, 1 isotope-labelled standard, 4 metabolites or hydroxylated analogues and 1 degradation product. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Naltrexone 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 Naltrexone 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 Naltrexone 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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