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Impurity reference standards

Acetophenone impurity standards

For Acetophenone, the Zemixal catalogue holds 11 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 nitrosamine, 2 isotope-labelled standards and 1 metabolite or hydroxylated analogue.

11reference materials
1nitrosamines
2isotope labelled
1metabolites

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

Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, desmethyl and conjugated forms

Counts are based on product names. One compound can fall into more than one type.

All Acetophenone reference materials

1–11 of 11 standards
Questions

Acetophenone impurities, answered

What Acetophenone reference materials are available?
The catalogue currently lists 11 compounds for Acetophenone, including 1 nitrosamine, 2 isotope-labelled standards and 1 metabolite or hydroxylated analogue. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Acetophenone 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 Acetophenone 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 Acetophenone nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Acetophenone. 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 Acetophenone 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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