2025 Spring International Convention of
The Pharmaceutical Society of Korea

2025 Spring
International Convention of PSK

04.21(MON) - 04.22(TUE)
D-37

Abstracts

P8-1

Study to mordernize assay methods in the korean pharmacopoeia

  • Hyo Bin Yang1, Hyeon Joo Ham*1, Ja Young Kim*1, Hee yeon Choi*1, Gyeong Ran Um*1, Kyung Hun Son*1
  • 1Drug Research Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Korea

The Korean Pharmacopoeia(KP) is the standard for pharmaceutical quality control, significantly impacting the pharmaceutical industry. The current KP contains more than 2,000 monographs with different dates of enactment and revision, including methods that may not align with changes in the industry. In particular, the titration method using indicators is difficult to ensure accuracy and consistency of test results because it is judged visually.In this study, we improved accuracy and precision by changing the indicator-based assay method to potentiometric titration. Five APIs—isoniazid, caffeine anhydrous, caffeine hydrate, chlorpheniramine maleate, and tifepidine hibenzate—were selected for the study items, which were reported to be in urgent need of revision in the pharmaceutical field. The established method using 0.1 M perchloric acid as titrant was fully validated. All five APIs showed specific and selective responses without interference at constant potentials. Linearity was confirmed in the range of 80~120% of test solution concentration (R2=0.9996~1.000). Accuracy (99.5~100.5%) and precision (0.0~0.08%) also met within standards, suggesting that it could replace outdated test methods.Based on these results, revised monographs for the five APIs were prepared, and it is expected that this will increase the usability of the KP by providing modernized test methods and contribute to improving the quality control level and quality of distributed pharmaceuticals.


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TODAY 2025. 03. 15

2025 Spring Convention

D-37

Conference infomation

Conference Schedule
Apr. 21(Mon) ~ 22(Tue), 2025
Conference Venue
Daegu Exhibition & Convention Center (EXCO) 10 Exco-ro, Buk-gu, Daegu, Republic of Korea
Location
Early Registration Period
Feb. 24(Mon) ~ Mar. 21(Fri), 2025
Abstract Submission Period
Feb. 24(Mon) ~ Mar. 21(Fri), 2025
Certificate of Attendance