1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Steering Committee, July 2000, Q3B(R) Impurities in New Drug Products, and AND As: Impurities in Drug Products,1999
2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Steering Committee,1995
3. This classification does not apply to biological/biotechnological, peptide, oligonucleotide, radiopharmaceutical, fermentation and semisynthetic products derived therefrom, herbal products, and crude products of animal or plant origin.
4. United States Pharmacopeia, 25, US Pharmacopeial Convention,2000