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Impurity reference standards

Benzocaine impurity standards

29 characterised compounds linked to Benzocaine are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 4 pharmacopoeial impurities, 1 nitrosamine and 3 isotope-labelled standards.

29reference materials
4pharmacopoeial
1nitrosamines
3isotope labelled
Benzocaine structure
Parent API

Benzocaine

CAS
94-09-7
Formula
C9H11NO2
MW
165.19 g/mol
Code
ZX-004024

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

Pharmacopoeial4EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled3Deuterated, 13C or 15N internal standards

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

All Benzocaine reference materials

1–29 of 29 standards
Questions

Benzocaine impurities, answered

How many Benzocaine impurity standards does Zemixal list?
The catalogue currently lists 29 compounds for Benzocaine, including 4 pharmacopoeial impurities, 1 nitrosamine and 3 isotope-labelled standards. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Benzocaine 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 Benzocaine 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 Benzocaine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Benzocaine. 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 Benzocaine standards available?
Yes. 3 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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