Reference : Transfer of active pharmaceutical ingredients (API) Raman library from bench top towa...
Scientific congresses and symposiums : Unpublished conference/Abstract
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/222938
Transfer of active pharmaceutical ingredients (API) Raman library from bench top towards handheld spectrometers
English
Clavaud, Matthieu mailto [Université de Liège - ULiège > > > Form. doct. sc. biomed. & pharma. (paysage)]
Sacre, Pierre-Yves mailto [Université de Liège - ULiège > Département de pharmacie > Chimie analytique >]
Hubert, Philippe mailto [Université de Liège - ULiège > Département de pharmacie > Chimie analytique >]
Ziemons, Eric mailto [Université de Liège - ULiège > Département de pharmacie > Département de pharmacie >]
9-Sep-2018
Yes
No
International
International Syposium DA-PBA 2018
9-12 september 2018
KU Leuven
Leuven
Belgium
[en] Raman spectroscopy ; Handheld spectrometer ; Transfer ; Active Pharmaceutical Ingredients
[en] In the recent years, manufacturers have made progress miniaturizing Raman spectrometers. The pharmaceutical field is evolving rapidly. The performance of the spectrometers should be consistent with this change and should meet the practical needs of the end-users.
In this study, a library transfer from a donor benchtop Raman towards different Raman receiver devices, handheld or benchtop, was evaluated. The aim was to develop a method on a lab spectrometer and transfer it to other systems for raw material or finished goods identification. However, the Raman spectrometers use different excitation wavelengths, optical components, detectors and acquisition parameters which can be an issue.
A library composed of ten Active Pharmaceutical Ingredients (API) was used. The APIs were packed into two transparent polyethylene liners, hermetically closed, to reproduce the same packaging condition as in the production unit. A donor benchtop DXR SmartRaman (Thermo Fisher Scientific®) and receivers composed of a benchtop RXN1 (Kaiser Optical System®), and two handheld spectrometers respectively Truscan (Thermo Fisher Scientific®) and MIRA M-1 (Metrohm Schweiz AG®) were selected. The large spectral range of 50-3371cm-1 and the low spectral resolution of 5 cm-1 were the two main arguments for the selection the DXR as the donor. On the other hand, the receiver instruments were different spectrometers with different technologies and acquisition parameters. All spectrometers were equipped with a 785 nm near infrared excitation laser to avoid variation in laser differences.
Four steps set up the evaluation strategy. First, the Orbital-Raster-Scanning (ORS) technology available with the MIRA M-1 was evaluated using two point-and-shoot adapters. Understanding the effect of the ORS technique on APIs was a previous step before setting up a database transfer experiment. Then, acetaminophen was used for library standardization applying Raman shift-axis correction. The objective was to calibrate the x-axis of the Raman spectrometers using Raman shift standard scatterers. Acetaminophen was chosen as is recommended by the European Pharmacopoeia since it contains well-known peaks in the fingerprint spectral region. Acetaminophen was also selected since it presents the same galenical form as the analyzed APIs. Additionally, the APIs were analyzed on each spectrometer. Finally, Raman spectra were mathematically preprocessed by using a first derivative Savitzky-Golay (polynome 2) prior to computation of the Hit-Quality Index (HQI) algorithm correlation method. A HQI correlation limit at 95% was defined.
A transfer between DXR-RXN1 was possible for 7 APIs confirmed by HQI values above 95%, while 3 APIs HQI values around 94% were observed. Regarding transfer possibilities between DXR-MIRA, 9 APIs presented HQI values higher than 95% while for one API the value was around 94%. The API was different than the ones observed between DXR-RXN1. Transfer between DXR-Truscan also highlighted good results with 8 APIs presenting HQI values higher than 95% while for two APIs the values were around 94%. These last APIs provided also similar results with DXR-RXN1 showing that they could potentially not be transferred. Nevertheless, an HQI of maximum 75% was observed between the different APIs which is much lower than the HQI value of 94%. This shows that a transfer can potentially even be possible for these 2 APIs.
In conclusion, transferring an API library from a benchtop Raman system towards handheld systems is possible. The next challenges would be validating the methods for an end-use in a GMP environment and to deal with Health authorities and customers during the filing.
Centre Interdisciplinaire de Recherche sur le Médicament - CIRM
Researchers ; Professionals
http://hdl.handle.net/2268/222938

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