Impurity reference standards
Fenofibrate impurity standards
For Fenofibrate, the Zemixal catalogue holds 17 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 3 pharmacopoeial impurities and 2 metabolites or hydroxylated analogues.
17reference materials
3pharmacopoeial
2metabolites
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. 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
Pharmacopoeial3EP, USP, BP or JP named impurities
Metabolites2Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Fenofibrate reference materials
1–17 of 17 standards
(4-Chlorophenyl)[4-(1-methylethoxy)phenyl]methanone
- CAS
- 154356-96-4
- Formula
- C16H15ClO2
- MW
- 274.74 g/mol
ZX-021667
2-(4-(4-Hydroxybenzoyl)phenoxy)-2-methylpropanoic acid
- CAS
- 61002-27-5
- Formula
- C17H16O5
- MW
- 300.3 g/mol
ZX-029467
Fenofibric Acid 1-Carboxyl-1-methylethyl Ester
- CAS
- 1797121-54-0
- Formula
- C21H21ClO6
- MW
- 404.8 g/mol
ZX-024719
Questions
Fenofibrate impurities, answered
What Fenofibrate reference materials are available?
The catalogue currently lists 17 compounds for Fenofibrate, including 3 pharmacopoeial impurities and 2 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Fenofibrate 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 Fenofibrate 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.