Elemental impurities According to ICH Q3D
ICH Q3D Step4 will have to be applied very soon: June 2016 for new Drug Products and 1st January 2018 for all existing DP, making it mandatory for all manufacturers to carry out a risk assessment to control elemental impurities in their DP.
Watch the conference given by Philippe De Raeve, Scientific Director at Quality Assistance
Fast and accurate absolute-quantification by ICP-MS
The fruit of a 2 year internal R&D project, Quality Assistance has overcome the challenge of developing and validating a fast and accurate method for absolute-quantification of proteins and antibodies using Isotope Dilution -Triple Quadrupole ICP-MS.