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Impurity reference standards

Ciprofloxacin impurity standards

For Ciprofloxacin, the Zemixal catalogue holds 25 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 7 pharmacopoeial impurities, 1 nitrosamine and 1 isotope-labelled standard.

25reference materials
7pharmacopoeial
1nitrosamines
1isotope labelled
Ciprofloxacin HCl structure
Parent API

Ciprofloxacin HCl

CAS
86393-32-0
Formula
C17H21ClFN3O4
MW
385.8 g/mol
Code
ZX-003918

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. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial7EP, 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 Ciprofloxacin reference materials

1–25 of 25 standards
Questions

Ciprofloxacin impurities, answered

What Ciprofloxacin reference materials are available?
The catalogue currently lists 25 compounds for Ciprofloxacin, including 7 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 Ciprofloxacin 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 Ciprofloxacin 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 Ciprofloxacin nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Ciprofloxacin. 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 Ciprofloxacin 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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