IRSpirit – fast and easy to perform contaminant ATR-FTIR analysis on drug tablet surface

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  • Published: May 14, 2018
  • Author: Shimadzu
  • Source: Shimadzu
  • Copyright: Shimadzu
  • Suppliers: Shimadzu Corporation
  • Channels: Infrared Spectroscopy
thumbnail image: IRSpirit – fast and easy to perform contaminant ATR-FTIR analysis on drug tablet surface

Pharmaceutical products must be controlled during all process steps, from raw materials to the final and ready to use product. In fact, strong regulations exist (e.g. European pharmacopeia) in order to guarantee drug quality and to protect customer health. Many analyses are therefore required especially in case of contamination by unknown materials. ATR-FTIR is probably the most useable technique for identification of contaminants, but the procedure can be difficult to perform in the short time required during production so as to avoid significant economic losses. Shimadzu’s new compact IRSpirit FTIR is a valuable solution with its unique combination of high performance and easy-to-use interface.

IRSpirit: able to solve analytical challenges under the strongest regulation

Despite a footprint smaller than an A3 sheet of paper, IRSpirit spectrophotometer integrates an advanced optical system and temperature controlled DLATGS detector which provide its high  sensitivity and resolution with S/N ratio of up to 30 000:1. For ATR measurement, IRSpirit can be enhanced with a specifically designed QATR-S device. This accessory is recognized automatically by the system software.

Figure 1. IRSpirit spectrometer with QATR-S accessory installed.

In addition to its performance, IRSpirit and the associated software LabSolutions DB/CS addresses to all regulation requirements. In fact, a validation program compliant with Chinese, European, US and Japanese Pharmacopoeias is integrated. Moreover, LabSolutions DB/CS software is FDA CFR part 11 compliant. This software enables solid security for data management with lockout functions to prevent illegal access, and register user’s deletion and change.

IRPilot: Contaminant identification has never been so easy

LabSolutions software features an innovative and easy to handle user’s interface: IRPilot. In fact, 4 different kinds of analysis are available directly on the IRpilot main menu: identification test, contaminant analysis, and quantitative analysis and film thickness studies. Users can also add 4 additional specific methods.

Figure 2. IRPilot main menu screenshot.

This interface makes users able to perform ATR-FTIR analysis measurement without the need for parameter registration. During all process measurements, only a few user actions are required. When contaminant analysis is selected, the QATR-S accessory is detected automatically by the software. The  user only needs to select the ATR prism type (see Figure 3).

Figure 3. ATR Prism selection menu.

After selecting the prism, a screen to select the execution of the background measurement is displayed and the background measurement is performed. When the background measurement is completed, a screen to indicate the sample setting is then displayed. After pressing a sample against the prism, sample measurement is performed by clicking the “OK” button.

When the sample measurement is finished, IRPilot automatically asks the user if  correction is required. Classic ATR correction requires the input of parameters such as incident angle and the number of reflections, which are contained in the instruction manual of an ATR attachment. With IRPilot and IRSpirit accessory automatic recognition system, these parameters are pre-selected automatically (Figure 4).

Figure 4. IRPilot ATR correction window screenshot

ATR correction is then performed automatically. Setting of search parameters is not necessary as it is done automatically. After the spectrum search, results are saved and can be printed. The report including an infrared spectrum of the sample is printed with infrared spectra of the first to third matches in the search result for comparison. A list with up to 20th match is also printed. Of course, contaminant nature is also indicated clearly. 

Figure 5. Example of contaminant identification report from IRPilot.

 

Direct identification of surface contamination on tablet

Despite the rigorous controls in pharmaceutical manufacturing, surface defects are sometimes detected during visual examination of tablets. In Figure 6 an acetylsalicylic acid tablet shows a dark irregular contaminant on its surface. The Area of this contaminant is around 1.2 mm².

Figure 6. Contaminant on tablet surface.

The position and size of this contaminant make in-situ ATR-FTIR with IRSpirit and QATR-S possible. Measurement conditions are summarised in Table 1.

Table 1. Measurement conditions for contaminant analysis of acetylsalicylic acid tablet

With IRPilot software and IRSpirit, an IR-spectrum of the contaminant is quickly obtained by direct ATR-FTIR analysis of the tablet default. Contaminant spectrum is shown as the black trace in Figure 7.

Figure 7. Analysis of in situ contaminant using QATR-S.

The library search results highlight two likely sample components, acetylsalicylic acid (green spectrum in Figure 7) and acetaminophen (red spectrum in Figure 7). The analysis therefore shows that the contaminant is acetaminophen, as the tablet matrix is acetylsalicylic acid.

 

Conclusion

Together with the IRPilot interface, IRSpirit with the QATR-S accessory is able to perform a fast and easy contaminant identification on drug tablets without any sample preparation. These measurements are compliant with the strongest requirements of pharmaceutical field regulations (CFR part 11 compliance…) and can be conducted easily, even by unspecialized users.

 

For more information, please view the following application notes:

Contaminant Analysis on Tablet Surface using the IRSpirit

Identification of Contaminant Found in Resin Production Process Using IR Pilot

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