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Impurity reference standards

Norfloxacin impurity standards

For Norfloxacin, the Zemixal catalogue holds 14 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 10 pharmacopoeial impurities, 1 nitrosamine and 1 isotope-labelled standard.

14reference materials
10pharmacopoeial
1nitrosamines
1isotope labelled

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial10EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards

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

All Norfloxacin reference materials

1–14 of 14 standards
Questions

Norfloxacin impurities, answered

What Norfloxacin reference materials are available?
The catalogue currently lists 14 compounds for Norfloxacin, including 10 pharmacopoeial impurities, 1 nitrosamine and 1 isotope-labelled standard. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Norfloxacin 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 Norfloxacin 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 Norfloxacin nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Norfloxacin. 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 Norfloxacin 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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