Impurity reference standards
Darifenacin impurity standards
Zemixal lists 28 reference materials related to Darifenacin, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 nitrosamine, 2 metabolites or hydroxylated analogues and 1 degradation product.
28reference materials
1nitrosamines
2metabolites
1degradants
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
Metabolites2Hydroxy, 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 Darifenacin reference materials
1–28 of 28 standards
(R)-2,2-Diphenyl-2-(pyrrolidin-3-yl)acetamide 2,3-dihydroxysuccinate
- CAS
- 1092540-94-7
- Formula
- C22H26N2O7
- MW
- 430.5 g/mol
ZX-028859
(S)-2,2-Diphenyl-2-(pyrrolidin-3-yl)acetonitrile hydrobromide
- CAS
- 194602-27-2
- Formula
- C18H19BrN2
- MW
- 343.3 g/mol
ZX-033272
Questions
Darifenacin impurities, answered
How many Darifenacin impurity standards does Zemixal list?
The catalogue currently lists 28 compounds for Darifenacin, including 1 nitrosamine, 2 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 Darifenacin 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 Darifenacin 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 Darifenacin nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Darifenacin. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.