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Impurity reference standards

Trimetazidine impurity standards

This page brings together 16 Trimetazidine related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 10 pharmacopoeial impurities and 1 nitrosamine.

16reference materials
10pharmacopoeial
1nitrosamines
Trimetazidine structure
Parent API

Trimetazidine

CAS
13171-25-0
Formula
C14H24Cl2N2O3
MW
339.3 g/mol
Code
ZX-004112

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

Pharmacopoeial10EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work

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

All Trimetazidine reference materials

1–16 of 16 standards
Questions

Trimetazidine impurities, answered

What Trimetazidine reference materials are available?
The catalogue currently lists 16 compounds for Trimetazidine, including 10 pharmacopoeial impurities and 1 nitrosamine. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Trimetazidine 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 Trimetazidine 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 Trimetazidine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Trimetazidine. 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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