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2. International Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254
3. ICH Q2A: Text on Validation of Analytical Procedures, October 1994
4. ICH Q2B: Validation of Analytical Procedures: Methodology, November 1996
5. ICH Q3A: Impurities in New Drug Substances, March 1995