The 2002 edition also harmonized with USP 25 and EP 2002 on residual solvent limits (Class 1, 2, and 3 solvents), aligning Japan with global ICH Q3C guidelines.
The is a significant regulatory document issued by the Japanese Ministry of Health, Labour and Welfare (MHLW). It serves as an official compendium of standards for pharmaceutical substances and preparations that are not included in the primary Japanese Pharmacopoeia (JP) . Key Overview Japanese Pharmaceutical Codex 2002
Much like the JP, the Codex opens with general rules regarding nomenclature, storage, and testing methodology. The 2002 edition saw updates in analytical technology. As High-Performance Liquid Chromatography (HPLC) became the gold standard for purity testing, the Codex 2002 expanded its general test methods to include more precise chromatographic conditions, moving away from older, less specific titration methods where appropriate. The 2002 edition also harmonized with USP 25
: It typically covers items that have a long history of use in Japan but do not meet the specific criteria for inclusion in the "main" Japanese Pharmacopoeia. Key Overview Much like the JP, the Codex