Ropivacaine EP Impurity A

Validation of a capillary electrophoresis method for the enantiomeric purity testing of ropivacaine, a new local anaesthetic compound
C.E Sänger-van de Griend K Gröningsson
Journal of Pharmaceutical and Biomedical Analysis Volume 14, Issue 3, January 1996, Pages 295-304
 
LC Method Development and Validation for the Determination of Ropivacaine Hydrochloride in Bulk Drug and Pharmaceutical Formulations
Sridevi Chigurupati, Raju Nemela Appala, Kesavanarayanan Krishnan Selvarajan, Chu How Khaw, Chun Foo Teoh, Livyashry Batumanathan, and Jahidul Islam Mohammad
Pharmaceutical Chemistry Journal 51(1):1-10
 
Quantitative Mass Spectrometric Analysis of Ropivacaine and Bupivacaine in Authentic, Pharmaceutical and Spiked Human Plasma without Chromatographic Separation
Nahla N. Salama and Shudong Wang
Anal Chem Insights. 2009; 4: 11–19.
 
Lack of metabolic racemisation of ropivacaine, determined by liquid chromatography using a chiral AGP column
Torbjörn Arvidsson  Heidi Forsmo Bruce  Magnus M. Halldin
Chirality Volume7, Issue4 1995 Pages 272-277

Ropivacaine EP Impurity A is chemically (S)-bupivacaine. Ropivacaine EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Ropivacaine 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 Ropivacaine.

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.