Page 127 - 2020Taiwan Food and Drug Administration Annual Report

Table 11c Amendments for the Chinese Pharmacopoeia and the publication of the
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“Chinese Pharmacopoeia edition VIII” VXSSOHPHQW
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New Monographs 199 1.The test methods and acceptance criteria for nitrosamine
impurities in sartan-type active pharmaceutical ingredients were
Monographs in 136 added to provide real-time important information.
Amendments 2.The following were addedjApplication of Nuclear Magnetic
Resonance Spectroscopy, Mid-Infrared Spectroscopy,
Active pharmaceutical Ultraviolet-Visible Spectroscopy, Capsules-Dissolution Testing
ingredients with domestic 8 DQG 5HODWHG 4XDOLW\ $WWULEXWHV 0LFURELRORJLFDO ([DPLQDWLRQ RI
characteristics Nonsterile Products: Acceptance Criteria for Pharmaceutical
Preparations and Substances for Pharmaceutical Use, Analytical
New General Chapters 31 Procedures Recombinant Therapeutic Monoclonal Antibodies,
Validation of Alternative Microbiological Methods, etc.
General Chapters in 29 3.Documented the eight active pharmaceutical ingredients
Amendments such as Potassium Cresolsulfonate, Granisetron, Calcipotriol
Monohydrate, Travoprost which were developed and
Total 403 manufactured by domestic companies, to promote the
development of domestic industries.

T able 12
Table 12c Additional TFDA Analytical Test Methods Form in 2019
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promulgated Poison
methods 2.Method of Test for Heavy Metals in Bottled (Packaged) Drinking Water and
(25 articles, Ice Cubes
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7.Method of Test for Preservatives in Foods
8.Methods of Test for Specifications of (6S)-5-Methyl-tetrahydrofolic acid,
Glucosamine Salt as Food Raw Material
9.Method of Test for Veterinary Drug Residues in Foods - Test of Multiresidue
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10.Method of Test for Pesticide Residues in Foods - Multiresidue Analysis (5)
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and Tolfenamic acid
14.Method of Test for Veterinary Drug Residues in Foods - Method for
Multiresidue Analysis (2)
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