Impurity reference standards
Doxepin impurity standards
For Doxepin, the Zemixal catalogue holds 16 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 3 pharmacopoeial impurities, 2 isotope-labelled standards and 2 degradation products.
16reference materials
3pharmacopoeial
2isotope labelled
2degradants
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. 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
Pharmacopoeial3EP, USP, BP or JP named impurities
Isotope labelled2Deuterated, 13C or 15N internal standards
Degradants2N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Doxepin reference materials
1–16 of 16 standards
Questions
Doxepin impurities, answered
What Doxepin reference materials are available?
The catalogue currently lists 16 compounds for Doxepin, including 3 pharmacopoeial impurities, 2 isotope-labelled standards 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 Doxepin 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 Doxepin 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 Doxepin standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.