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Impurity reference standards

Prednisolone impurity standards

48 characterised compounds linked to Prednisolone are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 12 pharmacopoeial impurities and 4 metabolites or hydroxylated analogues.

48reference materials
12pharmacopoeial
4metabolites
Prednisolone structure
Parent API

Prednisolone

CAS
50-24-8
Formula
C21H28O5
MW
360.4 g/mol
Code
ZX-004141

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. 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

Pharmacopoeial12EP, USP, BP or JP named impurities
Metabolites4Hydroxy, desmethyl and conjugated forms

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

All Prednisolone reference materials

1–48 of 48 standards
Questions

Prednisolone impurities, answered

How many Prednisolone impurity standards does Zemixal list?
The catalogue currently lists 48 compounds for Prednisolone, including 12 pharmacopoeial impurities and 4 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 Prednisolone 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 Prednisolone 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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