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Impurity reference standards

Mesalazine impurity standards

This page brings together 24 Mesalazine related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 5 pharmacopoeial impurities, 9 metabolites or hydroxylated analogues and 1 degradation product.

24reference materials
5pharmacopoeial
9metabolites
1degradants
Mesalazine structure
Parent API

Mesalazine

CAS
89-57-6
Formula
C7H7NO3
MW
153.14 g/mol
Code
ZX-004199

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. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.

By impurity type

Pharmacopoeial5EP, USP, BP or JP named impurities
Metabolites9Hydroxy, desmethyl and conjugated forms
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Mesalazine reference materials

1–24 of 24 standards
Questions

Mesalazine impurities, answered

What Mesalazine reference materials are available?
The catalogue currently lists 24 compounds for Mesalazine, including 5 pharmacopoeial impurities, 9 metabolites or hydroxylated analogues 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 Mesalazine 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 Mesalazine 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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