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KMID : 1142220170120020129
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Regulatory Research on Food, Drug & Cosmetic
2017 Volume.12 No. 2 p.129 ~ p.137
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Comparison Study on the General Test Methods of the Korean and Chinese Pharmacopoeia to Support Export on Domestic Drugs
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Kim Hyung-Min
Na Eui-Yeon
Kim Dan-Ah
Hong Yu-Jin
Kwon Sung-Won
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Abstract
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The main purpose of the Pharmacopoeia is to improve the public health by managing the quality of drugs. Although the composition of the Pharmacopoeia varies slightly according to each country, there are common parts which are general rules, official monographs and general test methods. The general test method is a set of representative test methods used in the monographs of pharmacopoeia. It could be a useful reference compendium when performing the quality control of the drugs. These general test methods can be differ depending on the country. Therefore, even if the test items are same, they could be tested in different method by each country. The difference in the testing methods can be confusing and is an important issue for pharmaceutical companies doing international trade business. In this study, we compared general test methods between the Korean and the Chinese Pharmacopoeia, which is one of the major exporting countries in the pharmaceutical industry. Also, we summarized major differences of general test methods to expedite international trading process in the pharmaceutical industries.
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KEYWORD
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Korean Pharmacopoeia, Chinese Pharmacopoeia, general test methods
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