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Impurity reference standards

Fluticasone impurity standards

For Fluticasone, the Zemixal catalogue holds 33 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 13 pharmacopoeial impurities and 3 metabolites or hydroxylated analogues.

33reference materials
13pharmacopoeial
3metabolites
Fluticasone Propionate structure
Parent API

Fluticasone Propionate

CAS
80474-14-2
Formula
C25H31F3O5S
MW
500.6 g/mol
Code
ZX-004172

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

Pharmacopoeial13EP, USP, BP or JP named impurities
Metabolites3Hydroxy, desmethyl and conjugated forms

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

All Fluticasone reference materials

1–33 of 33 standards
Questions

Fluticasone impurities, answered

What Fluticasone reference materials are available?
The catalogue currently lists 33 compounds for Fluticasone, including 13 pharmacopoeial impurities and 3 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 Fluticasone 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 Fluticasone 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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