Shipping to 128 countriesCOA and SDS with every lotQuotes within one business day
Bulk CASAccount
Impurity reference standards

Imatinib impurity standards

For Imatinib, the Zemixal catalogue holds 32 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 8 pharmacopoeial impurities, 1 nitrosamine, 1 metabolite or hydroxylated analogue and 2 degradation products.

32reference materials
8pharmacopoeial
1nitrosamines
1metabolites
Imatinib structure
Parent API

Imatinib

CAS
220127-57-1
Formula
C30H35N7O4S
MW
589.7 g/mol
Code
ZX-004215

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. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial8EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Metabolites1Hydroxy, 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 Imatinib reference materials

1–32 of 32 standards
Questions

Imatinib impurities, answered

What Imatinib reference materials are available?
The catalogue currently lists 32 compounds for Imatinib, including 8 pharmacopoeial impurities, 1 nitrosamine, 1 metabolite or hydroxylated analogue 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 Imatinib 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 Imatinib 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 Imatinib nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Imatinib. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.

Nearby APIs in the index

Compare 0 of 4Compare now