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KMID : 1142220090040010045
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Regulatory Research on Food, Drug & Cosmetic
2009 Volume.4 No. 1 p.45 ~ p.50
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Revision of the Supplement for The Korean Pharmaceutical Codex the Third Edition
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Choi Bo-Kyung
Kim Young-Ok
Kim Dong-Sub
Sohn Kyung-Hee
Um So-Young
Kim Dong-Hwan
Lee Eun-Sun
Kim Hye-Ji
Park So-Ra
Kim Hee-Sung
Kim Hye-Soo
Lee Su-Jung
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Abstract
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「The Korean Pharmaceutical Codex」 was published to set specifications for pharmaceuticals which are not listed in「The Korean Pharmacopeia」. 「The Korean Pharmaceutical Codex」is a collection of specifications for domestic drugs to be notified by the KFDA along with the Korean Pharmacopeia. The 3rd Edition of the Korean Pharmaceutical Codex was revised in 2007. In addition, the 3rd Edition was amended with the three separate Supplements to reflect changes in list of approved drug products and developed test methods. To minimize confusion related to drug quality control, the next Supplement specifies that all tests defined in 'General Requirements for Preparations' are described in the Monographs as with the 9th Edition of the Korean Pharmacopeia. That is intended to ensure that no essential test items are omitted (e.g. Disintegration Test for Tablets/Capsules, Sterility Test for Injections etc.). Furthermore, the next Supplement chose 42 articles to be deleted in order to reflect the withdrawn drugs and prepared specifications for 149 articles selected out of「The Korean Standards for Antibiotics」which is expected to be abolished. For some articles, there are changes in the
Method of Preparation, Names of Article as well as Test Methods.
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KEYWORD
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Drug, The 3rd Edition of the Korean Pharmaceutical Codex, Supplement
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