Solifenacin EP Impurity I

Solifenacin EP Impurity I is chemically (3R)-3-[[(1S)-1-Phenyl-3,4-dihydroisoquinoline-2(1H)-carbonyl]oxy]-1-azabicyclo[2.2.2]octane 1-oxide (as per EP). It is also known as Solifenacin N-Oxide (EP). Solifenacin EP Impurity I is supplied with detailed characterization data compliant with regulatory guideline. Solifenacin EP Impurity I 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 Solifenacin.

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.

Stability-indicating HPTLC method for the simultaneous detection and quantification of alfuzosin hydrochloride, solifenacin succinate along with four of their official impurities
Mahmoud A.Tantawy Soheir A.Weshahy Mina Wadie Mamdouh R.Rezk
Microchemical Journal Volume 157, September 2020, 104905
 
A novel HPLC-DAD method for simultaneous determination of alfuzosin and solifenacin along with their official impurities induced via a stress stability study; investigation of their degradation kinetics
Mahmoud A. Tantawy, Soheir A. Weshahy, Mina Wadie and  Mamdouh R. Rezk
Anal. Methods, 2020,12, 3368-3375
 
Efficient and single pot process for the preparation of enantiomerically pure solifenacin succinate, an antimuscarinic agent
Navnath C. Niphade, Kunal M. Jagtap, Anil C. Mali, Pavankumar V. Solanki, Madhukar N. Jachak & Vijayavitthal T. Mathad
Monatshefte für Chemie - Chemical Monthly volume 142, Article number: 1181 (2011)
 
A Validated Rapid Stability-Indicating Method for the Determination of Related Substances in Solifenacin Succinate by Ultra-Fast Liquid Chromatography
S. Radha Krishna, B.M. Rao, and N. Someswara Rao
Journal of Chromatographic Science, Vol. 48, November/December 2010

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• Controlled substance charges need to follow as per quotation. The specific inputs are required for controlled substance because regulatory status will differ based on destination.
• Cold Shipment Charges needs to be considered as per quotation.
• For ice pack there are no additional charges.

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