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Impurity reference standards

Donepezil impurity standards

40 characterised compounds linked to Donepezil are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 6 pharmacopoeial impurities, 6 metabolites or hydroxylated analogues and 3 degradation products.

40reference materials
6pharmacopoeial
6metabolites
3degradants
Donepezil structure
Parent API

Donepezil

CAS
120014-06-4
Formula
C24H29NO3
MW
379.5 g/mol
Code
ZX-006507

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. 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

Pharmacopoeial6EP, USP, BP or JP named impurities
Metabolites6Hydroxy, desmethyl and conjugated forms
Degradants3N-oxides, dimers, lactones and breakdown products

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

All Donepezil reference materials

1–40 of 40 standards
Questions

Donepezil impurities, answered

How many Donepezil impurity standards does Zemixal list?
The catalogue currently lists 40 compounds for Donepezil, including 6 pharmacopoeial impurities, 6 metabolites or hydroxylated analogues and 3 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Donepezil 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 Donepezil 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.
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