Comparison of quantitative analysis techniques for the determination of heat seal lacquer layers on aluminum blister foils.
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.
Mühlfeld
Lukas
L
Department of Biopharmaceutics and Pharmaceutical Technology, Institute of Pharmacy and Biochemistry, Johannes Gutenberg-University of Mainz, Staudinger Weg 5, 55099 Mainz, Germany.
Langguth
Peter
P
Häusler
Heribert
H
Hagels
Hansjörg
H
D000535:Aluminum / Q000737:chemistry; D002138:Calibration / Q000592:standards; D004349:Drug Packaging / Q000379:methods*; D006358:Hot Temperature; D007368:Interferometry; D008956:Models, Chemical; D010969:Plastics / Q000737:chemistry* / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D012542:Scattering, Radiation; D013055:Spectrophotometry, Infrared
D010969:Plastics; D000535:Aluminum