Doxepin EP impurity B

Doxepin EP impurity B is chemically (11RS)-11-[3-(Dimethylamino)propyl]-6,11-dihydrodibenzo[b,e]oxepin-11-ol (doxepinol). It is also known as Doxepin USP Related Compound B. Doxepin EP impurity B is supplied with detailed characterization data compliant with regulatory guideline. Doxepin EP impurity B 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 Doxepin.

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.

Use of TLC with Densitometric Detection for Determination of Impurities in Chlorpromazine Hydrochloride, Trifluoperazine Dihydrochloride, Promazine Hydrochloride, and Doxepin Hydrochloride
Anna Maślanka and Jan Krzek
JPC – Journal of Planar Chromatography – Modern TLC volume 20, pages463–475(2007)
 
Determination of therapeutic and toxic concentrations of doxepin and loxapine using gas—liquid chromatography with a nitrogen-sensitive detector, and gas chromatography—mass spectrometry of loxapine
John vasiliades, tuomah m. sahawneh and carmen owens
Journal of Chromatography B: Biomedical Sciences and Applications Volume 164, Issue 4, 1 December 1979, Pages 457-470

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