1. [1] ICH guideline, Good manufacturing practice guide for active pharmaceutical ingredients Q7A, Fed. Regist. 2001, 66, 49028-49029.
2. [2] ICH guideline, Specifications: Test procedures and acceptable criteria for new drug substances and new drug products: Chemical substances Q6A, Fed. Regist. 2000, 65, 83041-83063.
3. [3] ICH guideline, Specifications: Test procedures and acceptable criteria for biotechnological/biological products Q6B, Fed. Regist. 1999, 64, 44928.
4. [4] Itoda, Y.; Hasegawa, T.; Saito, S.; Itai, S.; Sai, Y.; Ogiwara, T. Iryoyakugaku 2014, 40, 304-309.
5. [5] Oda, M.; Furuto, Y.; Ichimura, Y.; Mori, M.; Takahashi, M.; Saitoh H. Iryoyakugaku 2020, 46, 606-612.