Page 138 - 2023 Taiwan Food and Drug Administration Annual Report
P. 138
2023 Taiwan Food and
Drug Administration
Annual Report
▍ Exhibit 11 Additions/ Elaborations to the Taiwan Pharmacopeia, Ninth Edition, First
Supplement
Category Number Remarks the addition and elaboration to the Taiwan Pharmacopeia, Ninth
of Edition, First Supplement
New
Monographs articles
Monographs 13 I. Referring to the pharmacopeia of advanced countries, the test
Elaborations technologies and quality specifications were elaborated and added,
New General including Microbiological Best Laboratory Practices, Depyrogenation,
Chapters
203 Quality of Biotechnological Products: Analysis of the Expression Construct
General in Cells Used for Production of r-DNA Derived Protein Products, Vaccines
Chapters
Elaborations for Human Use—Bacterial Vaccines, Identification of Fixed Oils by Thin-
Total 15 Layer Chromatography, Near-Infrared Spectroscopy, and Nephelometry
and Turbidimetry.
II. In order to harmonize with international pharmacopoeias, some
monographs were added and elaborated such as Alumina and
15 Magnesium Carbonate Tablets, Amlodipine and Benazepril Hydrochloride
Capsules, Abiraterone Acetate Tablets, and Acetaminophen. To retain the
domestic characteristics, active pharmaceutical ingredient, Cloperastine
246 Hydrochloride, which was developed and synthesized by domestic
manufacturers, was added.
136
