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Impurity reference standards

Olanzapine impurity standards

For Olanzapine, the Zemixal catalogue holds 26 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, 3 metabolites or hydroxylated analogues and 2 degradation products.

26reference materials
3pharmacopoeial
2isotope labelled
3metabolites
Olanzapine structure
Parent API

Olanzapine

CAS
132539-06-1
Formula
C17H20N4S
MW
312.4 g/mol
Code
ZX-004053

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

Pharmacopoeial3EP, USP, BP or JP named impurities
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites3Hydroxy, 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 Olanzapine reference materials

1–26 of 26 standards
Questions

Olanzapine impurities, answered

What Olanzapine reference materials are available?
The catalogue currently lists 26 compounds for Olanzapine, including 3 pharmacopoeial impurities, 2 isotope-labelled standards, 3 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 Olanzapine 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 Olanzapine 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 Olanzapine 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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