Impurity reference standards
Rupatadine impurity standards
For Rupatadine, the Zemixal catalogue holds 12 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 2 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue and 1 degradation product.
12reference materials
2pharmacopoeial
1metabolites
1degradants
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. 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
Pharmacopoeial2EP, 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 Rupatadine reference materials
1–12 of 12 standards
Questions
Rupatadine impurities, answered
What Rupatadine reference materials are available?
The catalogue currently lists 12 compounds for Rupatadine, including 2 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 Rupatadine 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 Rupatadine 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.