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Impurity reference standards

Zopiclone impurity standards

For Zopiclone, the Zemixal catalogue holds 14 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 3 pharmacopoeial impurities, 2 isotope-labelled standards and 1 metabolite or hydroxylated analogue.

14reference materials
3pharmacopoeial
2isotope labelled
1metabolites
Zopiclone structure
Parent API

Zopiclone

CAS
43200-80-2
Formula
C17H17ClN6O3
MW
388.8 g/mol
Code
ZX-006922

Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples.

By impurity type

Pharmacopoeial3EP, USP, BP or JP named impurities
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Zopiclone reference materials

1–14 of 14 standards
Questions

Zopiclone impurities, answered

What Zopiclone reference materials are available?
The catalogue currently lists 14 compounds for Zopiclone, including 3 pharmacopoeial impurities, 2 isotope-labelled standards and 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 Zopiclone 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 Zopiclone 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 Zopiclone 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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