Impurity reference standards
Tamoxifen impurity standards
For Tamoxifen, the Zemixal catalogue holds 18 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 7 pharmacopoeial impurities, 1 isotope-labelled standard, 6 metabolites or hydroxylated analogues and 1 degradation product.
18reference materials
7pharmacopoeial
1isotope labelled
6metabolites
Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. 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
Pharmacopoeial7EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites6Hydroxy, desmethyl and conjugated forms
Degradants1N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Tamoxifen reference materials
1–18 of 18 standards
4'-Hydroxy Tamoxifen-d6 (contains up to 10% E isomer)
- CAS
- 1346606-80-1
- Formula
- C26H29NO2
- MW
- 393.5 g/mol
ZX-043169
Questions
Tamoxifen impurities, answered
What Tamoxifen reference materials are available?
The catalogue currently lists 18 compounds for Tamoxifen, including 7 pharmacopoeial impurities, 1 isotope-labelled standard, 6 metabolites or hydroxylated analogues and 1 degradation product. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Tamoxifen 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 Tamoxifen 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 Tamoxifen standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.