caa a22 4500 445804092 CHVBK 20180317145151.0 cr unu---uuuuu 170323e20111201xx s 000 0 eng 10.1007/s10337-011-2149-5 doi (NATIONALLICENCE)springer-10.1007/s10337-011-2149-5 Use of a Single Capillary Electrophoresis Method as a Routine Identity Test for Batch Release of a Range of Pharmaceutical Products [Elektronische Daten] [Kevin Altria, Nigel Barker, Mairwen Hayworth, Alex Henderson] Two independent and orthogonal analytical methods are required when performing identity testing of pharmaceutical products during routine release testing. A microemulsion electrokinetic chromatography method has been developed and validated for routine use as an identity test to release various pharmaceutical products including tablets, capsules and creams. Implementation of the method involved optimisation of parameters to achieve reliable routine operation. Rinsing procedures, in particular, were found to be essential to obtain consistent profiles and migration times. The method has replaced, and offers the potential to replace, a number of methods including HPLC and IR due to the considerable cost and time savings obtained through its use. This method has been successfully approved by the US FDA as a part of 2 New Drug Applications, is registered in Japan, and is in routine QA use within a factory environment. Springer-Verlag, 2011 Capillary electrophoresis nationallicence Microemulsion electrokinetic chromatography nationallicence Routine nationallicence Identity confirmation nationallicence Pharmaceutical products nationallicence Altria Kevin Pharmaceutical Development Department, GlaxoSmithKline Research & Development, Harlow, Essex, UK aut Barker Nigel QA Department, GlaxoSmithKline, Crawley, West Sussex, UK aut Hayworth Mairwen QA Department, GlaxoSmithKline, Crawley, West Sussex, UK aut Henderson Alex QA Department, GlaxoSmithKline, Crawley, West Sussex, UK aut Chromatographia Springer-Verlag 74/11-12(2011-12-01), 783-787 0009-5893 74:11-12<783 2011 74 10337 https://doi.org/10.1007/s10337-011-2149-5 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s10337-011-2149-5 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Altria Kevin Pharmaceutical Development Department, GlaxoSmithKline Research & Development, Harlow, Essex, UK aut NATIONALLICENCE 700 1- Barker Nigel QA Department, GlaxoSmithKline, Crawley, West Sussex, UK aut NATIONALLICENCE 700 1- Hayworth Mairwen QA Department, GlaxoSmithKline, Crawley, West Sussex, UK aut NATIONALLICENCE 700 1- Henderson Alex QA Department, GlaxoSmithKline, Crawley, West Sussex, UK aut NATIONALLICENCE 773 0- Chromatographia Springer-Verlag 74/11-12(2011-12-01), 783-787 0009-5893 74:11-12<783 2011 74 10337 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer