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Impurity reference standards

Paracetamol impurity standards

This page brings together 30 Paracetamol related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 12 pharmacopoeial impurities, 3 nitrosamines, 2 isotope-labelled standards, 4 metabolites or hydroxylated analogues and 1 degradation product.

30reference materials
12pharmacopoeial
3nitrosamines
2isotope labelled
Paracetamol structure
Parent API

Paracetamol

CAS
103-90-2
Formula
C8H9NO2
MW
151.16 g/mol
Code
ZX-004011

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. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial12EP, USP, BP or JP named impurities
Nitrosamines3N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites4Hydroxy, 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 Paracetamol reference materials

1–30 of 30 standards
Questions

Paracetamol impurities, answered

What Paracetamol reference materials are available?
The catalogue currently lists 30 compounds for Paracetamol, including 12 pharmacopoeial impurities, 3 nitrosamines, 2 isotope-labelled standards, 4 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 Paracetamol 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 Paracetamol 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 Paracetamol nitrosamine impurities?
Yes. 3 N-nitroso compounds are listed for Paracetamol. 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 Paracetamol 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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