Impurity reference standards
Ethinylestradiol impurity standards
Zemixal lists 19 reference materials related to Ethinylestradiol, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 9 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue and 2 degradation products.
19reference materials
9pharmacopoeial
1metabolites
2degradants
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. 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
Pharmacopoeial9EP, USP, BP or JP named impurities
Metabolites1Hydroxy, desmethyl and conjugated forms
Degradants2N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Ethinylestradiol reference materials
1–19 of 19 standards
beta-Estradiol 17-(beta-D-glucuronide) sodium salt
- CAS
- 15087-02-2
- Formula
- C24H31NaO8
- MW
- 470.5 g/mol
ZX-033432
Questions
Ethinylestradiol impurities, answered
How many Ethinylestradiol impurity standards does Zemixal list?
The catalogue currently lists 19 compounds for Ethinylestradiol, including 9 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue and 2 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Ethinylestradiol 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 Ethinylestradiol 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.