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Impurity reference standards

Estradiol impurity standards

For Estradiol, the Zemixal catalogue holds 42 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 13 pharmacopoeial impurities, 1 isotope-labelled standard and 4 metabolites or hydroxylated analogues.

42reference materials
13pharmacopoeial
1isotope labelled
4metabolites
Estradiol Valerate structure
Parent API

Estradiol Valerate

CAS
979-32-8
Formula
C23H32O3
MW
356.5 g/mol
Code
ZX-004127

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

Pharmacopoeial13EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites4Hydroxy, desmethyl and conjugated forms

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

All Estradiol reference materials

1–42 of 42 standards
Questions

Estradiol impurities, answered

What Estradiol reference materials are available?
The catalogue currently lists 42 compounds for Estradiol, including 13 pharmacopoeial impurities, 1 isotope-labelled standard 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 Estradiol 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 Estradiol 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 Estradiol 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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