API fingerprinting using discriminatory analytical and chemometric techniques – a useful tool for authentication of API samples
Session
Pharmaceutical and Natural Sciences
Description
An API (Active pharmaceutical ingredient) fingerprint is a specific analytical profile that can reveal information on manufacturing and distribution history of the substance based of characteristic physicochemical properties. Determining fingerprints can allow differentiation between samples by origin (manufacturer or location), verification of suspicious samples, and successful detection of counterfeit medicines. The aim of the research was to develop and apply analytical and statistical methodology for API fingerprinting that would allow their authentication and prevent falsification. We will evaluate different chemical APIs, starting with the most common analytical techniques (such as related substances with HPLC, solvent residue by GC, information from FTIR spectra), following by evaluation of the obtained data using chemometrics (pattern recognition techniques) to be able to differentiate the origin of the API based on 'unique analytical features' (i.e. fingerprints). If simple techniques are not enough to distinguish between samples, we will run the analysis using more powerful techniques such as Raman spectroscopy, NIR (near infrared spectroscopy) and possibly XRD (X-ray diffraction). Test results will be processed by comprehensive statistics methods (chemometric). The results from fingerprinting are expected to help API characterization, improving methods for quality control, distinguishing between samples, identifying the source (origin) of the substance, detecting counterfeiting.
Keywords:
Active pharmaceutical ingredient fingerprinting, Pattern recognition techniques, Chemometrics
Proceedings Editor
Edmond Hajrizi
ISBN
978-9951-550-50-5
Location
UBT Kampus, Lipjan
Start Date
29-10-2022 12:00 AM
End Date
30-10-2022 12:00 AM
DOI
10.33107/ubt-ic.2022.98
Recommended Citation
Mehmeti, Gentiana; Mehmeti, Gentrida; Hoxha, Ahmet; Qazimi, Bujar; and Acevska, Jelena, "API fingerprinting using discriminatory analytical and chemometric techniques – a useful tool for authentication of API samples" (2022). UBT International Conference. 98.
https://knowledgecenter.ubt-uni.net/conference/2022/all-events/98
API fingerprinting using discriminatory analytical and chemometric techniques – a useful tool for authentication of API samples
UBT Kampus, Lipjan
An API (Active pharmaceutical ingredient) fingerprint is a specific analytical profile that can reveal information on manufacturing and distribution history of the substance based of characteristic physicochemical properties. Determining fingerprints can allow differentiation between samples by origin (manufacturer or location), verification of suspicious samples, and successful detection of counterfeit medicines. The aim of the research was to develop and apply analytical and statistical methodology for API fingerprinting that would allow their authentication and prevent falsification. We will evaluate different chemical APIs, starting with the most common analytical techniques (such as related substances with HPLC, solvent residue by GC, information from FTIR spectra), following by evaluation of the obtained data using chemometrics (pattern recognition techniques) to be able to differentiate the origin of the API based on 'unique analytical features' (i.e. fingerprints). If simple techniques are not enough to distinguish between samples, we will run the analysis using more powerful techniques such as Raman spectroscopy, NIR (near infrared spectroscopy) and possibly XRD (X-ray diffraction). Test results will be processed by comprehensive statistics methods (chemometric). The results from fingerprinting are expected to help API characterization, improving methods for quality control, distinguishing between samples, identifying the source (origin) of the substance, detecting counterfeiting.