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Deconinck E, Courselle P, Raimondo M, et al. GEONs API fingerprint project: Selection of analytical techniques for clustering of sildenafil citrate API samples. Talanta. 2021;239:123123doi: 10.1016/j.talanta.2021.123123.
Deconinck, E., Courselle, P., Raimondo, M., Grange, Y., Rebière, H., Mihailova, A., Bøyum, O., Maurin, J. K., Pioruńska-Sędłak, K., Olsen, L. S., Acevska, J., Brezovska, K., Rundlöf, T., Portela, M. J., & Bertrand, M. (2021). GEONs API fingerprint project: Selection of analytical techniques for clustering of sildenafil citrate API samples. Talanta, 239123123. https://doi.org/10.1016/j.talanta.2021.123123
Deconinck, E, et al. "GEONs API fingerprint project: Selection of analytical techniques for clustering of sildenafil citrate API samples." Talanta vol. 239 (2021): 123123. doi: https://doi.org/10.1016/j.talanta.2021.123123
Deconinck E, Courselle P, Raimondo M, Grange Y, Rebière H, Mihailova A, Bøyum O, Maurin JK, Pioruńska-Sędłak K, Olsen LS, Acevska J, Brezovska K, Rundlöf T, Portela MJ, Bertrand M. GEONs API fingerprint project: Selection of analytical techniques for clustering of sildenafil citrate API samples. Talanta. 2021 Dec 02;239:123123. doi: 10.1016/j.talanta.2021.123123. Epub 2021 Dec 02. PMID: 34942486.
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Talanta. 2021 Dec 02;239:123123. doi: 10.1016/j.talanta.2021.123123. Epub 2021 Dec 02.

GEONs API fingerprint project: Selection of analytical techniques for clustering of sildenafil citrate API samples.

Talanta

E Deconinck, P Courselle, M Raimondo, Y Grange, H Rebière, A Mihailova, O Bøyum, J K Maurin, K Pioruńska-Sędłak, L Stengelshøj Olsen, J Acevska, K Brezovska, T Rundlöf, M J Portela, M Bertrand

Affiliations

  1. OMCL Active Pharmaceutical Ingredient (API) Working Group, GEON Network, EDQM - Council of Europe, 7 Allée Kastner, CS 30026, F-67081, Strasbourg, France; Scientific Direction Chemical and Physical Health Risks, Service of Medicines and Health Products, Sciensano, J. Wytsmanstraat 14, B-1050, Brussels, Belgium. Electronic address: [email protected].
  2. Scientific Direction Chemical and Physical Health Risks, Service of Medicines and Health Products, Sciensano, J. Wytsmanstraat 14, B-1050, Brussels, Belgium.
  3. OMCL Active Pharmaceutical Ingredient (API) Working Group, GEON Network, EDQM - Council of Europe, 7 Allée Kastner, CS 30026, F-67081, Strasbourg, France; Istituto Superiore di Sanità, National Centre for the Control and Evaluation of Medicines, Chemical Medicines Unit, Viale Regina Elena 299, 00161, Rome, Italy.
  4. OMCL Active Pharmaceutical Ingredient (API) Working Group, GEON Network, EDQM - Council of Europe, 7 Allée Kastner, CS 30026, F-67081, Strasbourg, France; French National Agency for Medicines and Health Products Safety, Laboratory Controls Division, 635 Rue de la Garenne, 34740, Vendargues, France.
  5. French National Agency for Medicines and Health Products Safety, Laboratory Controls Division, 635 Rue de la Garenne, 34740, Vendargues, France.
  6. OMCL Active Pharmaceutical Ingredient (API) Working Group, GEON Network, EDQM - Council of Europe, 7 Allée Kastner, CS 30026, F-67081, Strasbourg, France; Norwegian Medicines Agency, Grensesvingen 26, NO-0663, Oslo, Norway.
  7. Norwegian Medicines Agency, Grensesvingen 26, NO-0663, Oslo, Norway.
  8. OMCL Active Pharmaceutical Ingredient (API) Working Group, GEON Network, EDQM - Council of Europe, 7 Allée Kastner, CS 30026, F-67081, Strasbourg, France; National Medicines Institute, 30/34 Chelmska Str., 00-725, Warsaw, Poland.
  9. National Medicines Institute, 30/34 Chelmska Str., 00-725, Warsaw, Poland.
  10. Danish Medicines Agency, Medicines Control and Inspection Division, Axel Heides Gade 1, 2300, Copenhagen S, Denmark.
  11. OMCL Active Pharmaceutical Ingredient (API) Working Group, GEON Network, EDQM - Council of Europe, 7 Allée Kastner, CS 30026, F-67081, Strasbourg, France; Center for Drug Quality Control, Institute of Applied Chemistry and Pharmaceutical Analysis, Faculty of Pharmacy, University Ss.Cyril and Methodius, Majka Tereza 47, POB 36, 1000, Skopje, Republic of North-Macedonia.
  12. Center for Drug Quality Control, Institute of Applied Chemistry and Pharmaceutical Analysis, Faculty of Pharmacy, University Ss.Cyril and Methodius, Majka Tereza 47, POB 36, 1000, Skopje, Republic of North-Macedonia.
  13. OMCL Active Pharmaceutical Ingredient (API) Working Group, GEON Network, EDQM - Council of Europe, 7 Allée Kastner, CS 30026, F-67081, Strasbourg, France; Swedish Medical Products Agency, Laboratory, Box 26, Dag Hammarskjölds Väg 42, SE-751 03, Uppsala, Sweden.
  14. OMCL Active Pharmaceutical Ingredient (API) Working Group, GEON Network, EDQM - Council of Europe, 7 Allée Kastner, CS 30026, F-67081, Strasbourg, France; INFARMED, Autoridade Nacional Do Medicamento e Produtos de Saúde, I.P. Parque de Saúde de Lisboa, Avenida Do Brasil, 531749-004, Lisboa, Portugal.
  15. OMCL Active Pharmaceutical Ingredient (API) Working Group, GEON Network, EDQM - Council of Europe, 7 Allée Kastner, CS 30026, F-67081, Strasbourg, France.

PMID: 34942486 DOI: 10.1016/j.talanta.2021.123123

Abstract

Through its Active Pharmaceutical Ingredient Working Group (API-WG) the General European Official Medicines Control Laboratory (OMCL) Network (GEON), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM), regularly organises market surveillance studies for specific APIs for conformity to their monograph in the European Pharmacopoeia. During the past years some studies were combined with a fingerprint study of the APIs. The idea is to obtain a fingerprint for each manufacturer of the API under investigation, allowing the OMCL network to identify future samples as well as to detect substandard and falsified APIs. This paper reports the results of the latest fingerprint study, organised on sildenafil citrate API samples. Seventy-nine samples from 14 different manufacturers were collected throughout the Network. Fingerprint data was collected through Mid-Infrared spectroscopy, Raman spectroscopy, liquid chromatography for related substances, gas chromatography for residual solvents, X-ray diffraction and Nuclear Magnetic Resonance (NMR) spectroscopy. Chemometrics applied to the collected data showed that all manufacturers could be discriminated based on the data of only three of these tests, i.e. gas chromatography for residual solvents, X-ray diffraction and proton NMR. Suspicious API samples for sildenafil citrate will therefore be analysed in the future with the selected techniques in order to link the sample to a manufacturer or demonstrate the absence of such link. If the sample cannot be attributed to one of the manufacturers, further analysis and research on provenance and identity will be required. Of course, if the suspected sample claims to originate from one of the manufacturers included in the study, analysis can be limited to the test distinguishing this manufacturer.

Copyright © 2021 Elsevier B.V. All rights reserved.

Keywords: APIs; Fingerprint; GEON/OMCL Network; Illegal medicinal products; Sildenafil citrate

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