Pharmaceuticals

The Korean Pharmacopoeia; (31 page(s), in Korean)

The purpose of the revision is to secure pharmaceutical quality control based on achieved international harmonization of criteria/specification in 「Korean Pharmacopoeia」, to improve some criteria/specifications and general tests to the latest scientific level with reflecting opinions from the pharmaceutical industries, ultimately, to advance criteria/specifications and circulate high quality pharmaceuticals.

1.    A term 'Rubber Closures for Aqueous Infusions' was changed into the term ' 'Rubber Closures for injectable drug' in General Notice, General Requirements for Pharmaceutical Preparations and General Test and the subject of application of the test method was expanded. An international harmonization for the test method including addition of performance test of the rubber closures and replacement of animal test by the biological reactivity test.

2.    A definition 'In principle, there should be no foreign substances in an ophthalmic solution.' and a paragraph ''foreign insoluble matter test for Ophthalmic Suspension is not performed in the the General Requirements for Pharmaceutical Preparations.

3.    A test method for 9 items including herbal medicinal preparations such as Soyo Granule in Part 2 of any article was revised.

4.    A term 'LOD(Limit of Detection) in items such as 5. Verification and 5.2. Quantitative test(lower concentration e,g, quantitative test for impurity) was deleted, test parameters including specificity, accuracy, precision was changed into parameters including specificity and LOD in an item, 5.4 Limit test (reference concentration close to the limit of quantitation) and an item 5.5. Limit test (reference concentration significantly higher than the limit of quantitation) was deleted in 'Guideline of Validation of Analytical Procedures for Pharmaceuticals' in General Information.