Diphenhydramine EP Impurity A

Control of impurities in diphenhydramine hydrochloride by an ion-pairing, reverse-phase liquid chromatographic method
L. Henderson, J. H. McB. Miller and G. G. Skellern
Journal of Pharmacy and Pharmacology, JPP 2001, 53: 323–331.
 
Selective determination of dimenhydrinate in presence of six of its related substances and potential impurities using a direct GC/MS method
Tarek S.Belal, Karim M.Abdel-Hay, C. RandallClark
Journal of Advanced Research Volume 7, Issue 1, January 2016, Pages 53-58
 
Simultaneous estimation of dimenhydrinate, cinnarizine and their toxic impurities benzophenone and diphenylmethylpiperazine; in silico toxicity profiling of impurities
Nada S. Abdelwahab, ORCID logo a   Fadwa H. Edrees,b   Mohammed T. Alsaadi,cd   Noha H. Aminc  and  Ahmed S. Saad
RSC Adv., 2020, 10, 37439–37448.
 
Development and Validation of an UPLC Method for Rapid Determination of Ibuprofen and Diphenhydramine Citrate in the Presence of Impurities in Combined Dosage Form
Dantu Durga Rao, Shakil S. Sait, K. Mukkanti
Journal of Chromatographic Science, Volume 49, Issue 4, April 2011, Pages 281–286

Diphenhydramine EP Impurity A is chemically 2-(diphenylmethoxy)-N-methylethanamin hydrochloride. It is also known as Diphenhydramine USP Related Compound A ; N-Desmethyl diphenhydramine hydrochloride. Diphenhydramine EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Diphenhydramine EP Impurity A can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Diphenhydramine.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.