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Impurity reference standards

Lidocaine impurity standards

Zemixal lists 31 reference materials related to Lidocaine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 18 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard and 1 metabolite or hydroxylated analogue.

31reference materials
18pharmacopoeial
1nitrosamines
1isotope labelled
Lidocaine structure
Parent API

Lidocaine

CAS
137-58-6
Formula
C14H22N2O
MW
234.34 g/mol
Code
ZX-006614

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Pharmacopoeial18EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 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 Lidocaine reference materials

1–31 of 31 standards
Questions

Lidocaine impurities, answered

How many Lidocaine impurity standards does Zemixal list?
The catalogue currently lists 31 compounds for Lidocaine, including 18 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard 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 Lidocaine 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 Lidocaine 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 Lidocaine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Lidocaine. 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 Lidocaine 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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