English Translation of Supplement II to the Japanese Pharmacopoeia (JP18) Published

The official English translation of Supplement II to the Japanese Pharmacopoeia (JP) Eighteenth Edition has just been published.

Legal Status

The Japanese Pharmacopoeia is the pharmaceutical standard established by the Japanese Minister of Health, Labour and Welfare (MHLW) to regulate the properties and quality of drugs. Like other pharmacopoeias, it is revised periodically.

The 18th edition (JP18) came into effect on 07 June 2021. Supplement I to JP18 was published in 2022, and Supplement II in 2024. The texts are originally prepared in Japanese and are translated into English after the publication of the Japanese version, typically within one year. According to the publication schedule, the 19th edition is planned for release in 2026.

Content of Supplement II

The original Japanese version of Supplement II to the Japanese Pharmacopoeia Eighteenth Edition has been translated into English. The ministry emphasizes that the "English Version of the Japanese Pharmacopoeia is published for the convenience of users unfamiliar with the Japanese language. When and if any discrepancy arises between the Japanese original and its English translation, the former is authentic."

Supplement II includes the following sections on General Tests, Processes, and Apparatus:

• 2.03 Thin-layer Chromatography
• 2.46 Residual Solvents
• 2.66 Elemental Impurities
• 3.01 Determination of Bulk Density
• 3.07 Measurement of the Diameter of Particles Dispersed in Liquid by Dynamic Light Scattering
• 4.02 Microbial Assay for Antibiotics
• 5.01 Crude Drugs Test
• 9.01 Reference Standards
• 9.41 Reagents, Test Solutions
• 9.42 Solid Supports/Column Packings for Chromatography
• 9.62 Measuring Instruments, Appliances

Additionally, Supplement II includes new or updated official monographs, IR and UV reference spectra, and General Information. The General Information section includes:

• Analyses of Size and Morphology of Nanoparticles by Atomic Force Microscope <G1-9-182>
• Concept of Weighing in the Japanese Pharmacopoeia <G1-6-182>
• Calibration and Performance Check of a Balance, and Weights <G1-7-182>
• Installation Environment and Basic Handling Method of a Balance, and Precautions for Weighing <G1-8-182>
• Solid and Particle Densities <G2-1-182>
• Powder Flow <G2-3-182>
• Measurement of the Diameter of Particles Dispersed in Liquid by Dynamic Light Scattering <G2-4-161>
• Peptide Mapping <G3-3-182>
• Flow Cytometry <G3-16-182>
• Evaluation Method of Insoluble Particulate Matter in Biotechnological Products (Biopharmaceuticals) Drug Substances/Drug Products by Flow Imaging Method <G3-17-182>
• On the Scientific Names of Crude Drugs listed in the JP <G5-1-182>
• Thin-layer Chromatography for Crude Drugs and Crude Drug Preparations <G5-3-182>

Download

The official English translation of Supplement II to the Japanese Pharmacopoeia 18th Edition is available free of charge on the website of the Minister of Health, Labour and Welfare. Older editions of the pharmacopoeia are also accessible there.

Further information is also available in the JP Frequently Asked Questions section.