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Impurity reference standards

Fluorometholone impurity standards

Zemixal lists 14 reference materials related to Fluorometholone, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 pharmacopoeial impurity and 3 metabolites or hydroxylated analogues.

14reference materials
1pharmacopoeial
3metabolites
Fluorometholone structure
Parent API

Fluorometholone

CAS
426-13-1
Formula
C22H29FO4
MW
376.5 g/mol
Code
ZX-006556

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

Pharmacopoeial1EP, 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 Fluorometholone reference materials

1–14 of 14 standards
Questions

Fluorometholone impurities, answered

How many Fluorometholone impurity standards does Zemixal list?
The catalogue currently lists 14 compounds for Fluorometholone, including 1 pharmacopoeial impurity 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 Fluorometholone 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 Fluorometholone 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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