1. ICH Harmonized Tripartite Guideline, Stability Testing of New Drug Substances and Drug Products, Q1A(R2), Geneva, Switzerland, 2003.
2. ICH Harmonized Tripartite Guideline, Good Manufacturing Practices for Active Pharmaceutical Ingredients, Q7A, Geneva, Switzerland, 2001.
3. Note for guidance on stability testing of existing active substances and related finished products, Committee for Proprietary Medicinal Products, EMEA, London, 1998.
4. Therapeutic Products Directorate, Stability testing of existing drug substances and products, Ottawa, 1997.
5. Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products, in: WHO Technical Report Series, No. 953, WHO, Geneva, Switzerland, 2009, Annex 2.