Impurity reference standards
Norethindrone impurity standards
For Norethindrone, the Zemixal catalogue holds 22 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 14 pharmacopoeial impurities and 3 metabolites or hydroxylated analogues.
22reference materials
14pharmacopoeial
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
Pharmacopoeial14EP, 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 Norethindrone reference materials
1–22 of 22 standards
Questions
Norethindrone impurities, answered
What Norethindrone reference materials are available?
The catalogue currently lists 22 compounds for Norethindrone, including 14 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 Norethindrone 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 Norethindrone 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.