Paroxetine Hydrochloride Hemihydrate EP Impurity B

Development, validation and transfer into a factory environment of a liquid chromatography tandem mass spectrometry assay for the highly neurotoxic impurity FMTP (4-(4-fluorophenyl)-1-methyl-1,2,3,6-tetrahydropyridine) in paroxetine active pharmaceutical ingredient (API)
Phil J.Borman, Marion J.Chatfield, Elizabeth L.Crowley, ChristineEckers, David P.Elder, Scott W.Francey, Alice M.-F.Laures, Jean-ClaudeWolff
Journal of Pharmaceutical and Biomedical Analysis Volume 48, Issue 4, 1 December 2008, Pages 1082-1089
 
An Investigation into the Dehydration Behavior of Paroxetine HCl Form I Using a Combination of Thermal and Diffraction Methods: The Identification and Characterization of a New Anhydrous Form
M. Fátima Pina, Min Zhao, João F. Pinto, João J. Sousa, Christopher S. Frampton, Victor Diaz, Osama Suleiman, László Fábián, and Duncan Q. M. Craig
Cryst. Growth Des. 2014, 14, 8, 3774–3782
 
Determination of residual solvents in paroxetine by headspace gas chromatography
abdul rahaman sk, padmavathi sakinala, khaleel n, harekrishna roy
Asian J Pharm Clin Res, Vol 12, Issue 6, 2019, 150-155
 
Spectral Characterization of Degradation Impurities of Paroxetine Hydrochloride Hemihydrate
nirmala munigela, j. moses babu , anjaneyulu yerramilli , naveen kumar kolla , vyas krishnamurthy, vijay vittal mathad
Sci Pharm. 2008; 76; 653–661.

Paroxetine Hydrochloride Hemihydrate EP Impurity B is chemically (3S,4R)-3-[[(1,3-benzodioxol-5-yl)oxy]methyl]-4-(4-methoxyphenyl)piperidine hydrochloride (as per EP) ; (3S,4R)-3-[(Benzodioxol-5-yloxy)methyl]-4-(4-methoxyphenyl)piperidine hydrochloride (as per USP). It is also known as Paroxetine USP Related Compound A. Paroxetine Hydrochloride Hemihydrate EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Paroxetine Hydrochloride Hemihydrate 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 Paroxetine.

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.