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Impurity reference standards

Estrone impurity standards

16 characterised compounds linked to Estrone are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 1 pharmacopoeial impurity, 3 isotope-labelled standards and 3 metabolites or hydroxylated analogues.

16reference materials
1pharmacopoeial
3isotope labelled
3metabolites

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
Isotope labelled3Deuterated, 13C or 15N internal standards
Metabolites3Hydroxy, desmethyl and conjugated forms

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

All Estrone reference materials

1–16 of 16 standards
Questions

Estrone impurities, answered

How many Estrone impurity standards does Zemixal list?
The catalogue currently lists 16 compounds for Estrone, including 1 pharmacopoeial impurity, 3 isotope-labelled standards 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 Estrone 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 Estrone 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 Estrone standards available?
Yes. 3 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.
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