Impurity reference standards
Diphenhydramine impurity standards
This page brings together 16 Diphenhydramine related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 4 pharmacopoeial impurities, 1 isotope-labelled standard, 1 metabolite or hydroxylated analogue and 2 degradation products.
16reference materials
4pharmacopoeial
1isotope labelled
1metabolites
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 labelled1Deuterated, 13C or 15N internal standards
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 Diphenhydramine reference materials
1–16 of 16 standards
Diphenhydramine EP Impurity C (Freebase)/Dimenhydrinate EP Impurity H(Freebase)
- CAS
- 118-23-0
- Formula
- C17H20BrNO
- MW
- 334.2 g/mol
ZX-005665
Diphenhydramine EP Impurity C (HCl)/Dimenhydrinate EP Impurity H(HCl)
- CAS
- 1808-12-4
- Formula
- C17H21BrClNO
- MW
- 370.7 g/mol
ZX-005666
Questions
Diphenhydramine impurities, answered
What Diphenhydramine reference materials are available?
The catalogue currently lists 16 compounds for Diphenhydramine, including 4 pharmacopoeial impurities, 1 isotope-labelled standard, 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 Diphenhydramine 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 Diphenhydramine 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 Diphenhydramine standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.