Page 5 - Shimadzu’s Solutions for Impurities Analysis
P. 5
Response to FDA Regulations on Inorganic
Impurities
Inorganic impurities, such as metal from metal catalysts spectrometer and atomic absorption spectrophotometer
or manufacturing equipment used for the synthesis of are effective for the analysis of aluminum in infusions and
the pharmaceutical ingredients, are examples of metal catalysts used for the synthesis of pharmaceutical
impurities in pharmaceuticals. The ICP emission ingredients required under FDA 21 CFR Part 201.323.
Contents
Item Description Instrument Page
High-Performance Liquid
Chromatograph Mass Spectrometer P. 6
Structural Analysis of Ultra-trace Impurities
®
(LCMS-IT-TOF )
FDA Regulations on 2D-LC/LCMS-IT-TOF ® P. 8
Genotoxic Impurities High-Performance Liquid
Chromatograph Mass Spectrometer P. 10
Quantitation of Ultra-trace Impurities (LCMS-2020)
Co-Sense for Impurities P. 12
FDA Regulations on
Qualitative and Quantitative Analysis of Residual Solvents Headspace GC P. 14
Residual Solvents
FDA Regulations on ICP Emission Spectrometer P. 16
Qualitative and Quantitative Analysis of Inorganic Impurities
Inorganic Impurities Atomic Absorption Spectrophotometer P. 18
Support from Analytical Instrument Suitability Assessment P. 20
Shimadzu Data Management CLASS-Agent P. 22
