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Impurity reference standards

Ofloxacin impurity standards

This page brings together 14 Ofloxacin related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 6 pharmacopoeial impurities and 1 metabolite or hydroxylated analogue.

14reference materials
6pharmacopoeial
1metabolites
Ofloxacin structure
Parent API

Ofloxacin

CAS
82419-36-1
Formula
C18H20FN3O4
MW
361.4 g/mol
Code
ZX-003937

Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples.

By impurity type

Pharmacopoeial6EP, USP, BP or JP named impurities
Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Ofloxacin reference materials

1–14 of 14 standards
Questions

Ofloxacin impurities, answered

What Ofloxacin reference materials are available?
The catalogue currently lists 14 compounds for Ofloxacin, including 6 pharmacopoeial impurities 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 Ofloxacin 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 Ofloxacin 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.
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