The Applications of the COntent Uniformity Test and the Weight Variation Test on Process Validation Tests of Multiple Ingredient Preparations

スポンサーリンク

概要

• 論文の詳細を見る

• The new criteria for the weight variation test and the content uniformity test in general tests were revised in the Japanese Pharmacopoeia thirteenth edition (JPXIII), and both tests are used to determine the uniformity of dosage units. The weight variation test, if the content of an ingredient could be directed in the assay reported in JP13,replaces the content uniformity test. Although over-the-counter (OTC) drugs, for example medicine for coughs, are guaranteed to content uniformity, the applications of these tests have not been thoroughly investigated.We investigated whether one of the effective ingredients could be used as an indicator for the content uniformity of an OTC drug. The indicator was chosen by reason of the very small quantity compared to the others such as anhydrous caffeine in the case of cough medicine. When the mixing process was incomplete and the weight variation test was passed, the content uniformity of anhydrous caffeine in tablet varied in relative standard deviation and could not be guaranteed by this test, though both tests were passed as to the other ingredients. One ingredient such as anhydrous caffeine could not be used as arepresentative indicator for the other ingredients to confirm the content uniformity. And the content uniformity test could not be replaced by the weight variation test when the content uniformity of the mixed powder had not been confirmed. To guarantee the content uniformities of all effective ingredients of OTC drugs, the content uniformities in the mixing process should be confirmed respectively.

• 社団法人日本薬学会の論文
• 1999-05-15

著者

• Sakai Yoshimichi

  Gifu Prefectural Health And Environmental Research Center

• Sakai Yoshimichi

  Gifu Prefectural Institute Of Health And Environmental Sciences

• YOSHIDA Isao

  Gifu Prefectural Institute of Health and Environmental Sciences

• Yoshida Isao

  Gifu Prefectural Health And Environmental Research Center

関連論文

• The Applications of the COntent Uniformity Test and the Weight Variation Test on Process Validation Tests of Multiple Ingredient Preparations
• Magnolol-Induced Apoptosis Is Mediated via the Intrinsic Pathway with Release of AIF from Mitochondria in U937 Cells(Molecular and Cell Biology)
• PC62 EFFECTS OF CHINESE HERBAL MEDICINES ON THE MUTAGENIC ACTIVITY OF BENZO(A)PYRENE
• HPLC profiling of Phellinus linteus
• Determination of the 8-methyl ether of xanthurenic acid in human serum by high-performance liquid chromatography with fluorescence detection
• Polysaccharides in Fungi. XXXVII. Immunomodulating Activities of Carboxymethylated Derivatives of Linear (1→3)-α-D-Glucans Extracted from the Fruiting Bodies of Agrocybe cylindracea and Amanita muscaria

スポンサーリンク