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Impurity reference standards

Budesonide impurity standards

Zemixal lists 33 reference materials related to Budesonide, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 10 pharmacopoeial impurities, 2 isotope-labelled standards and 7 metabolites or hydroxylated analogues.

33reference materials
10pharmacopoeial
2isotope labelled
7metabolites
Budesonide structure
Parent API

Budesonide

CAS
51333-22-3
Formula
C25H34O6
MW
430.5 g/mol
Code
ZX-004161

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. 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

Pharmacopoeial10EP, USP, BP or JP named impurities
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites7Hydroxy, desmethyl and conjugated forms

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

All Budesonide reference materials

1–33 of 33 standards
Questions

Budesonide impurities, answered

How many Budesonide impurity standards does Zemixal list?
The catalogue currently lists 33 compounds for Budesonide, including 10 pharmacopoeial impurities, 2 isotope-labelled standards and 7 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 Budesonide 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 Budesonide 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 Budesonide standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.
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