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. (USP<735>, Ph.Eur.2.2.37)
Element Classification (24 Elements)
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).
Three Analytical and Measuring Instruments Win the Internationally Recognized “iF Design Award 2024”
The Shimadzu LCMS-2050 high-performance liquid chromatograph mass spectrometer, the Brevis GC-2050 gas chromatograph, and the ICPMS-2040/2050 ICP mass spectrometer won the internationally recognized iF Design Award 2024 in the product design category.
New Video: The Cabbage Core, Trash or Treasure?
Most people throw out the cabbage core when cooking, but is the core really just trash or actually a hidden treasure of nutrients?
New Video: ICPMS-2040/2050 ProActive Rinsing
ProActive Rinsing can shorten the analysis time by sharting the rinsing sequence in advance. While measuring multiple samples, the rinsing sequence can be started early by sending the autosampler probe to rinse while collecting data using sample already in the suction line. This greatly reduces measurement time and conserves sample.
New Video: ICPMS-2040/2050 Extended Rinsing
The extended rinsing function automatically performs an additional rinse sequence when a target element exceeds a predetermined upper limit. A second rinse solution can be used in the additional rinsing sequence to improve rinsing effectiveness. Consequently, carryover is eliminated to ensure high-quality data.
Shimadzu has released the ICPMS-2040 Series / ICPMS-2050 Series, Inductively Coupled Plasma Mass Spectrometry
ICPMS-2040/ 2050 Series has achieved a harmonious blend of environmental-friendliness and analytical performance.
The Shimadzu LCMS-2050 High-Performance Liquid Chromatograph Mass Spectrometer and the AA-7800 series of atomic absorption spectrophotometers have received the Red Dot Design Award 2023.
The Shimadzu LCMS-2050 High-Performance Liquid Chromatograph Mass Spectrometer and the AA-7800 series of atomic absorption spectrophotometers have received the Red Dot Design Award 2023.
