Comparison of quantitative analysis techniques for the determination of heat seal lacquer layers on aluminum blister foils
| Autor: | Lukas Mühlfeld, Peter Langguth, Hansjörg Hagels, Heribert Häusler |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Quality Control
Absorption (acoustics) Hot Temperature Materials science Spectrophotometry Infrared Backscatter Pharmaceutical Science engineering.material law.invention Optics Coating law Eddy current Scattering Radiation Electrical impedance Drug Packaging business.industry Linearity Reference Standards Interferometry Models Chemical Calibration engineering Gravimetric analysis Analytical procedures business Plastics Aluminum |
| Zdroj: | European Journal of Pharmaceutical Sciences. 41:700-706 |
| ISSN: | 0928-0987 |
| DOI: | 10.1016/j.ejps.2010.09.015 |
| Popis: | For decades a gravimetric method has been common standard for the determination of heat seal lacquers on aluminum blister foils. With the availability of appropriate techniques such as interferometric, infrared reflection absorption spectroscopic (IRRAS), beta backscatter, impedance spectroscopic and eddy current techniques respectively, more efficient determinations can be foreseen which are subject of the present communication. The different methods were compared to each other regarding parameters required for validation of analytical procedures according to the ICH guidelines Q2 (R1) such as linearity, precision, accuracy, robustness and quantitation limits. The interferometric, IRRAS and beta backscatter techniques were well suitable for the measurements. Using these techniques novel procedures applicable for routine quality control of pharmaceutical packaging materials are suggested. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect