<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Eric Deconinck</style></author><author><style face="normal" font="default" size="100%">Patricia Courselle</style></author><author><style face="normal" font="default" size="100%">M. Raimondo</style></author><author><style face="normal" font="default" size="100%">Y. Grange</style></author><author><style face="normal" font="default" size="100%">H. Rebiere</style></author><author><style face="normal" font="default" size="100%">A. Mihailova</style></author><author><style face="normal" font="default" size="100%">O. Bøyum</style></author><author><style face="normal" font="default" size="100%">J.K. Maurin</style></author><author><style face="normal" font="default" size="100%">K. Pioruńska-Sędłak</style></author><author><style face="normal" font="default" size="100%">L. Stengelshøj Olsen</style></author><author><style face="normal" font="default" size="100%">J. Acevska</style></author><author><style face="normal" font="default" size="100%">K. Brezovska</style></author><author><style face="normal" font="default" size="100%">T. Rundlöf</style></author><author><style face="normal" font="default" size="100%">M.J. Portela</style></author><author><style face="normal" font="default" size="100%">M. Bertrand</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">GEONs API fingerprint project: Selection of analytical techniques for clustering of sildenafil citrate API samples</style></title><secondary-title><style face="normal" font="default" size="100%">Talanta</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">APIs</style></keyword><keyword><style  face="normal" font="default" size="100%">fingerprint</style></keyword><keyword><style  face="normal" font="default" size="100%">GEON/OMCL network</style></keyword><keyword><style  face="normal" font="default" size="100%">illegal medicinal products</style></keyword><keyword><style  face="normal" font="default" size="100%">Sildenafil Citrate</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2022</style></year><pub-dates><date><style  face="normal" font="default" size="100%">Jan-03-2022</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">239</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;Through its Active Pharmaceutical Ingredient Working Group (API-WG) the General European Official Medicines&lt;br&gt;
Control Laboratory (OMCL) Network (GEON), co-ordinated by the European Directorate for the Quality of&lt;br&gt;
Medicines &amp;amp; HealthCare (EDQM), regularly organises market surveillance studies for specific APIs for conformity&lt;br&gt;
to their monograph in the European Pharmacopoeia. During the past years some studies were combined with a&lt;br&gt;
fingerprint study of the APIs. The idea is to obtain a fingerprint for each manufacturer of the API under investigation,&lt;br&gt;
allowing the OMCL network to identify future samples as well as to detect substandard and falsified&lt;br&gt;
APIs.&lt;br&gt;
This paper reports the results of the latest fingerprint study, organised on sildenafil citrate API samples.&lt;br&gt;
Seventy-nine samples from 14 different manufacturers were collected throughout the Network. Fingerprint data&lt;br&gt;
was collected through Mid-Infrared spectroscopy, Raman spectroscopy, liquid chromatography for related substances,&lt;br&gt;
gas chromatography for residual solvents, X-ray diffraction and Nuclear Magnetic Resonance (NMR)&lt;br&gt;
spectroscopy. Chemometrics applied to the collected data showed that all manufacturers could be discriminated&lt;br&gt;
based on the data of only three of these tests, i.e. gas chromatography for residual solvents, X-ray diffraction and&lt;br&gt;
proton NMR. Suspicious API samples for sildenafil citrate will therefore be analysed in the future with the&lt;br&gt;
selected techniques in order to link the sample to a manufacturer or demonstrate the absence of such link. If the&lt;br&gt;
sample cannot be attributed to one of the manufacturers, further analysis and research on provenance and&lt;br&gt;
identity will be required. Of course, if the suspected sample claims to originate from one of the manufacturers&lt;br&gt;
included in the study, analysis can be limited to the test distinguishing this manufacturer.&lt;/p&gt;
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