Flucloxacillin EP Impurity E

Development and validation for the determination of residual solvents of pharmaceutical formulations of flucloxacillin sodium using head space gas chromatography
By Haque, Sk Manirul
From African Journal of Pharmacy and Pharmacology (2014), 8(42), 1086-1092
 
LC-​MS​/TOF and MSn studies on forced degradation behavior of flucloxacillin and development of a validated stability indicating LC method
By Tiwari, R.; Bonde, C.; Bothara, K.
From Acta Chromatographica (2014), 26(1), 43-55, 13
 
Development and validation of a liquid chromatography​/tandem mass spectrometry method for the quantification of flucloxacillin and cloxacillin in microdialysis samples
By Larmene-Beld, Karin H. M.; Vries-Koenjer, Marie-Therese L. M.; ter Horst, Peter G. J.; Hospes, Wobbe
From Biomedical Chromatography (2014), 28(8), 1096-1101

Flucloxacillin EP Impurity E is chemically (2S,5R,6R)-6-[[[(2S,5R,6R)-6-[[[3-(2-chloro-6-fluorophenyl)-5-methyl-1,2-oxazol-4-yl]carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]hept-2-yl]carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid (as per EP). It is also known as 6-Aminopenicillanic Acid. Flucloxacillin EP Impurity E is supplied with detailed characterization data compliant with regulatory guideline. Flucloxacillin EP Impurity E 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 Flucloxacillin.

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.