Impurity reference standards
Doxylamine impurity standards
Zemixal lists 12 reference materials related to Doxylamine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 4 pharmacopoeial impurities, 2 isotope-labelled standards, 2 metabolites or hydroxylated analogues and 3 degradation products.
12reference materials
4pharmacopoeial
2isotope labelled
2metabolites
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
Pharmacopoeial4EP, USP, BP or JP named impurities
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites2Hydroxy, desmethyl and conjugated forms
Degradants3N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Doxylamine reference materials
1–12 of 12 standards
Doxylamine Succinate EP Impurity B Hydrochloride
- CAS
- 879671-67-7
- Formula
- C13H14ClNO
- MW
- 235.71 g/mol
ZX-029101
Questions
Doxylamine impurities, answered
How many Doxylamine impurity standards does Zemixal list?
The catalogue currently lists 12 compounds for Doxylamine, including 4 pharmacopoeial impurities, 2 isotope-labelled standards, 2 metabolites or hydroxylated analogues and 3 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Doxylamine 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 Doxylamine 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 Doxylamine standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.