The International Conference of Harmonisation (ICH) guidance document on elemental impurities, Q3D, reached step 4 in December 2014, meaning the final draft is recommended for adoption. This paper outlines the key timeframes for implementation in the EU and US and considerations for ensuring compliance.
- Excellence in Pharmaceutical Analysis
- Enhanced Sampling and Calibration Procedures for the Analysis of Residual Oxygen in Nitrogen Purged Pharmaceutical Packaging by GC-TCD
- Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Delivery, Storage and Analysis.
- A Method to Meet the New Ph Eur Ninhydrin-Positive Substances Requirement