Pharmaceutical Elemental Impurities Analysis System
Energy Dispersive X-ray Fluorescence Spectrometer
Control of Elemental Impurities in Pharmaceuticals
In the pharmaceutical industry, the analysis of elemental impurities is necessary to ensure the safety of pharmaceuticals. In December 2014, the "Guideline for Elemental Impurities" (Q3D) was issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), consisting of representatives from Europe, the U.S. and Japan. In Japan, the "Guideline for Elemental Impurities in Drug Products" (PFSB/ELD Notification 0930 #4 from the Ministry of Health, Labour and Welfare) was issued, and will be applied to new drug products submitted for approval after April 1 2017. For 24 elements categorized in Class 1 to Class 3, residual quantities in pharmaceutical drug products must be controlled within permissible limits. Although ICP-AES and ICP-MS are used for precise analysis of elemental impurities, X-ray fluorescence spectrometers can be used as an alternative analysis method. This is because they can quantitatively and qualitatively analyze a variety of elements nondestructively, and without chemical pretreatment, unlike ICP-AES and ICP-MS systems. The X-ray fluorescence spectrometry has been adopted as a general method of analysis in the U.S Pharmacopeia and the European Pharmacopoeia. (USP39<735>, Ph.Eur.2.2.37)
Element Classification (24 Elements)
- Class 1:Very toxic. Highly toxic in all administration routes.
- Class 2:Toxic, although it depends somewhat on the administration route.
- Class 2A：Assessment is required in all cases.
- Class 2AB：Assessment is required only when it is intentionally added in a process.
- Class 3:Toxicity is low in oral administration. Assessment is required for other administration routes.
PCEDX Pro Software
Analysis is performed using PCEDX Pro software. Easy-to-use operations enable fully automatic measurements, so even novices can feel confident. This highly functional software supports many quantitative calculations, including the calibration curve method, the fundamental parameters (FP) method, the thin film FP method, and the background FP method (patented by Shimadzu).