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Impurity reference standards

Olaparib impurity standards

Zemixal lists 49 reference materials related to Olaparib, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 nitrosamine, 3 metabolites or hydroxylated analogues and 1 degradation product.

49reference materials
1nitrosamines
3metabolites
1degradants
Olaparib structure
Parent API

Olaparib

CAS
763113-22-0
Formula
C24H23FN4O3
MW
434.5 g/mol
Code
ZX-006694

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Nitrosamines1N-nitroso impurities for ICH M7 work
Metabolites3Hydroxy, 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 Olaparib reference materials

1–49 of 49 standards
OPD-3A
CAS
763114-26-7
Formula
C16H11FN2O3
MW
298.27 g/mol
ZX-012739
Questions

Olaparib impurities, answered

How many Olaparib impurity standards does Zemixal list?
The catalogue currently lists 49 compounds for Olaparib, including 1 nitrosamine, 3 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 Olaparib 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 Olaparib 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.
Do you supply Olaparib nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Olaparib. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.

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