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Impurity reference standards

Bosentan impurity standards

Zemixal lists 27 reference materials related to Bosentan, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 4 pharmacopoeial impurities, 1 isotope-labelled standard and 5 metabolites or hydroxylated analogues.

27reference materials
4pharmacopoeial
1isotope labelled
5metabolites
Bosentan structure
Parent API

Bosentan

CAS
147536-97-8
Formula
C27H29N5O6S
MW
551.6 g/mol
Code
ZX-004082

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. 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

Pharmacopoeial4EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites5Hydroxy, desmethyl and conjugated forms

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

All Bosentan reference materials

1–27 of 27 standards
Questions

Bosentan impurities, answered

How many Bosentan impurity standards does Zemixal list?
The catalogue currently lists 27 compounds for Bosentan, including 4 pharmacopoeial impurities, 1 isotope-labelled standard and 5 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Bosentan 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 Bosentan 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 Bosentan 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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