2018; 294 pages; A4 Format (210 x 297 mm); Paperback; ISBN978-4-8408-1476-8
Published by Pharmaceutical and Medical Device Regulatory Science Society of Japan
Supplement 1 to JP XVII in English language comprises in order as follows;
The Ministry of Health, Labour and Welfare Ministerial Notification; Contents; Preface; General Rules for Preparations; General Tests, Processes and Apparatus; Official Monographs, including Crude Drugs and Related Drugs; Infrared Reference Spectra; Ultraviolet-visible Reference Spectra; General Information; Index; Index in Latin name; Index in Japanese; and Addenda.
The General Rules for Preparations which were newly added are:
1-8. Films for Oral Administration
1-8-1. Orally Disintegrating Films
The General Rules for Preparations which were revised are:
5-1-1. Dry Powder Inhalers
5-1-3. Metered-dose Inhalers, etc.
General Tests, Processes and Apparatus which were newly added are:
3.06 Laser Diffraction Measurement of Particle Size
6.14 Uniformity of Delivered Dose for Inhalations
6.15 Aerodynamic Particle Size Measurement for Inhalations.
General Tests, Processes and Apparatus which were revised are:
2.24 Ultraviolet-visible Spectrophotometry
2.46 Residual Solvents
4.03 Digestion Tes
6.02 Uniformity of Dosage Units
6.04 Test for Acid-neutralizing Capacity of Gastrointestinal Medicines, etc.
Official Monographs provides 163 articles, including 32 articles newly added, 17 articles deleted and 114 articles revised.