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Impurity Reference Standards

Metabolites & Degradation Products

Drug metabolites, N-oxides, sulphoxides and forced-degradation products for stability studies, DMPK work and impurity identification.
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Drugs change in the body and on the shelf. Metabolites arise from oxidation, dealkylation and conjugation in vivo, while degradation products form through hydrolysis, oxidation or light during storage. This sub-category supplies both groups, including (R)-Cetirizine N-Oxide, (S)-Emtricitabine Sulfoxide, 5-O-Desmethyl Omeprazole, 6-Desacetyl Palbociclib and (RS)-N-Despropyl Pramipexole.

Stability teams use these standards to identify peaks that grow during forced degradation and long-term studies. Bioanalytical teams use metabolites to build calibration curves and confirm metabolic pathways. In both cases a correct structure is vital, so each standard is supplied with HPLC purity and structural data from NMR and MS.

Many oxidised metabolites and degradants are themselves unstable, so they are packed cold in amber vials and should be stored as the label states. Quantities usually run from 5 mg to 100 mg. If you have isolated an unknown degradant, we can synthesise a proposed structure for confirmation.

Metabolites & Degradation Products: questions buyers ask

How do forced degradation studies use these standards?
Forced degradation exposes the API or product to acid, base, oxidation, heat and light to generate likely degradants. Standards of known degradation products help confirm which peaks formed, prove the method is stability-indicating and set specifications. They also support structural assignment when unknown peaks appear in long-term stability samples.
Why are N-oxides and sulphoxides often unstable?
These oxidised species can revert to the parent compound or rearrange under heat, light or acidic conditions. Some sulphoxides are also chiral and can racemise. Store them cold, dark and dry, prepare solutions just before use, and check purity if they have been stored for a long time.
Do you supply metabolites for DMPK and bioanalysis?
Yes. Many major metabolites of common drugs are listed and can be used as calibration standards or for metabolite identification. For regulated bioanalysis, pair them with labelled internal standards. If a specific metabolite is missing, send the structure and we will quote synthesis with full characterisation.

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