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Impurity reference standards

Macitentan impurity standards

28 characterised compounds linked to Macitentan are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 2 metabolites or hydroxylated analogues and 1 degradation product.

28reference materials
2metabolites
1degradants

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

Metabolites2Hydroxy, 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 Macitentan reference materials

1–28 of 28 standards
Questions

Macitentan impurities, answered

How many Macitentan impurity standards does Zemixal list?
The catalogue currently lists 28 compounds for Macitentan, including 2 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 Macitentan 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 Macitentan 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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