Bupivacaine EP Impurity B

Simultaneous determination of bupivacaine, mepivacain, prilocaine and ropivacain in human serum by liquid chromatography–tandem mass spectrometry
A. Koehler ∗, R. Oertel, W. Kirch
Journal of Chromatography A, 1088 (2005) 126–130
 
Racemisation of R-Bupivacaine: A Key Factor in the Integrated and Economic Process for the Production of Levobupivacaine
Marianne Langston,* Ulrich C. Dyer,† Graham A. C. Frampton, Gordon Hutton,‡ Christopher J. Lock, Benjamin M. Skead, Martin Woods,§ and Hooshang S. Zavareh
Organic Process Research & Development 2000, 4, 530−533
 
Investigation into spinal anesthetic failure with hyperbaric bupivacaine: the role of cold exposure on bupivacaine degradation
Ellen K. Wasan PhD, Calen Sacevich MD, Anas El-Aneed PhD, Munawar Mohammed MSc, Jaweria Syeda MPharm, Erin Neville BSP, Tatiana Orlowski, David Campbell MD & Jonathan Gamble MD
Canadian Journal of Anesthesia/Journal canadien d'anesthésie volume 66, pages803–812(2019)

Bupivacaine EP Impurity B is chemically (2RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide (as per EP). It is also known as N-Desbutyl Bupivacaine ; Bupivacaine USP Related Compound B . Bupivacaine EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Bupivacaine 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 Bupivacaine.

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.