Impurity reference standards
Flecainide impurity standards
Zemixal lists 17 reference materials related to Flecainide, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 4 pharmacopoeial impurities, 2 nitrosamines and 1 isotope-labelled standard.
17reference materials
4pharmacopoeial
2nitrosamines
1isotope labelled
Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. 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
Pharmacopoeial4EP, USP, BP or JP named impurities
Nitrosamines2N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Counts are based on product names. One compound can fall into more than one type.
All Flecainide reference materials
1–17 of 17 standards
1-(2,5-Bis(2,2,2-trifluoroethoxy)phenyl)ethanone
- CAS
- 76784-40-2
- Formula
- C12H10F6O3
- MW
- 316.2 g/mol
ZX-024760
2,2,2-Trifluoroethyl 2,5-Bis(2,2,2-trifluoroethoxy)benzoate
- CAS
- 50778-57-9
- Formula
- C13H9F9O4
- MW
- 400.19 g/mol
ZX-029523
Questions
Flecainide impurities, answered
How many Flecainide impurity standards does Zemixal list?
The catalogue currently lists 17 compounds for Flecainide, including 4 pharmacopoeial impurities, 2 nitrosamines and 1 isotope-labelled standard. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Flecainide 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 Flecainide 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 Flecainide nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Flecainide. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Flecainide standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.