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Impurity reference standards

Gatifloxacin impurity standards

This page brings together 14 Gatifloxacin related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 2 pharmacopoeial impurities, 1 isotope-labelled standard and 1 degradation product.

14reference materials
2pharmacopoeial
1isotope labelled
1degradants
Gatifloxacin structure
Parent API

Gatifloxacin

CAS
112811-59-3
Formula
C19H22FN3O4
MW
375.4 g/mol
Code
ZX-003927

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.

By impurity type

Pharmacopoeial2EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Gatifloxacin reference materials

1–14 of 14 standards
Questions

Gatifloxacin impurities, answered

What Gatifloxacin reference materials are available?
The catalogue currently lists 14 compounds for Gatifloxacin, including 2 pharmacopoeial impurities, 1 isotope-labelled standard 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 Gatifloxacin 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 Gatifloxacin 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.
Are isotope-labelled Gatifloxacin 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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