2902洋地黄胶囊由newp0rt1于东部时间11月23日星期三22453.pdfVIP

2902 Digitalis / Official Monographs USP 35 shows bands corresponding to them, and also shows bands Microbial enumeration tests 〈61〉 and Tests for specified corresponding to the 3 other bands most prominent in the microorganisms 〈62〉—It meets the requirements of the test chromatogram from Standard solution A but of lower RF value. for absence of Salmonella species. Relative RF values for the 5 bands are: 1.0 (digitoxin); 0.8 to 0.9 Disintegration 〈701〉: 30 minutes. (gitoxin); 0.6 to 0.7; 0.4 to 0.5; and 0.3 to 0.4. Uniformity of dosage units 〈905〉: meet the requirements. Microbial enumeration tests 〈61〉 and Tests for specified Assay— microorganisms 〈62〉—It meets the requirements of the test for absence of Salmonella species. Standard preparation—Prepare as directed in the Assay under Digitalis. Water, Method III, Procedure for Articles of Botanical Origin 〈921〉: not more than 5.0%. Assay preparation—Weigh and finely powder not fewer than 25 Tablets. Weigh accura y a portion of the powder, equiva- Acid-insoluble ash 〈561〉: not more than 5.0%. lent to not less than 20 T ablets. Transfer to a dr y, hard-glass, Assay—Proceed with Powdered Digitalis as directed in the As- glass-stoppered container of not less than 50-mL capacity. Pro- say under Digitalis. ceed as directed for the Assay preparation in the Assay under The potency of Powdered Digita