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Impurity reference standards

Desloratadine impurity standards

For Desloratadine, the Zemixal catalogue holds 26 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 3 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards, 7 metabolites or hydroxylated analogues and 1 degradation product.

26reference materials
3pharmacopoeial
1nitrosamines
2isotope labelled

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. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial3EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites7Hydroxy, 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 Desloratadine reference materials

1–26 of 26 standards
Questions

Desloratadine impurities, answered

What Desloratadine reference materials are available?
The catalogue currently lists 26 compounds for Desloratadine, including 3 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards, 7 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 Desloratadine 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 Desloratadine 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 Desloratadine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Desloratadine. 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 Desloratadine standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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