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Impurity reference standards

Oxybutynin impurity standards

This page brings together 16 Oxybutynin related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 5 pharmacopoeial impurities, 2 nitrosamines, 1 isotope-labelled standard, 1 metabolite or hydroxylated analogue and 1 degradation product.

16reference materials
5pharmacopoeial
2nitrosamines
1isotope labelled

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

By impurity type

Pharmacopoeial5EP, USP, BP or JP named impurities
Nitrosamines2N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
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 Oxybutynin reference materials

1–16 of 16 standards
Questions

Oxybutynin impurities, answered

What Oxybutynin reference materials are available?
The catalogue currently lists 16 compounds for Oxybutynin, including 5 pharmacopoeial impurities, 2 nitrosamines, 1 isotope-labelled standard, 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 Oxybutynin 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 Oxybutynin 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 Oxybutynin nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Oxybutynin. 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 Oxybutynin standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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