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Impurity reference standards

Montelukast impurity standards

For Montelukast, the Zemixal catalogue holds 47 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 9 pharmacopoeial impurities, 1 isotope-labelled standard, 8 metabolites or hydroxylated analogues and 2 degradation products.

47reference materials
9pharmacopoeial
1isotope labelled
8metabolites
Montelukast structure
Parent API

Montelukast

CAS
158966-92-8
Formula
C35H36ClNO3S
MW
586.2 g/mol
Code
ZX-004178

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.

By impurity type

Pharmacopoeial9EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites8Hydroxy, desmethyl and conjugated forms
Degradants2N-oxides, dimers, lactones and breakdown products

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

All Montelukast reference materials

1–47 of 47 standards
Questions

Montelukast impurities, answered

What Montelukast reference materials are available?
The catalogue currently lists 47 compounds for Montelukast, including 9 pharmacopoeial impurities, 1 isotope-labelled standard, 8 metabolites or hydroxylated analogues and 2 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Montelukast 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 Montelukast 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 Montelukast 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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