Impurity reference standards
Fexofenadine impurity standards
Zemixal lists 24 reference materials related to Fexofenadine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 7 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue and 1 degradation product.
24reference materials
7pharmacopoeial
1metabolites
1degradants
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. 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
Pharmacopoeial7EP, USP, BP or JP named impurities
Metabolites1Hydroxy, 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 Fexofenadine reference materials
1–24 of 24 standards
3-(Cyclopropylcarbonyl)-α,α-dimethylbenzeneacetic Acid
- CAS
- 162096-56-2
- Formula
- C14H16O3
- MW
- 232.27 g/mol
ZX-031390
4-(Cyclopropylcarbonyl)-α,α-dimethylbenzeneacetic Acid
- CAS
- 162096-54-0
- Formula
- C14H16O3
- MW
- 232.27 g/mol
ZX-024731
4-(Cyclopropylcarbonyl)-α,α-dimethylbenzeneacetic Acid Methyl Ester
- CAS
- 880088-78-8
- Formula
- C15H18O3
- MW
- 246.3 g/mol
ZX-024732
Cyclopropyl(4-(1-hydroxy-2-methylpropan-2-yl)phenyl)methanone
- CAS
- 169280-26-6
- Formula
- C14H18O2
- MW
- 218.29 g/mol
ZX-029490
Questions
Fexofenadine impurities, answered
How many Fexofenadine impurity standards does Zemixal list?
The catalogue currently lists 24 compounds for Fexofenadine, including 7 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue 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 Fexofenadine 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 Fexofenadine 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.