Dissolution Test

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Dr. Ricardo Ferreira-Nunes

Published on Dec 19, 2024
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The dissolution test makes it possible to determine the quantity of active substance dissolved in the dissolution medium when the product is subjected to the action of specific equipment, under described experimental conditions. The result is expressed as a percentage of the quantity declared on the label. This test is used to demonstrate whether the product meets the requirements set forth in the drug monograph in tablets; capsules and other cases in which the test is required. The tanks are immersed in a thermostated water bath, made of transparent material and of adequate size, in which the temperature is maintained at (37 ± 0.5) ºC during the execution of the test. The equipment must be free of any source of vibration, including external vibration, which may influence the hydrodynamics of the system. Preferably, the equipment should allow the visualization of the samples and the agitators during the test. Dissolution medium: The dissolution medium specified in the product monograph is used, previously degassed by a suitable procedure, when necessary, to avoid the formation of bubbles that may interfere with the dissolution speed of the pharmaceutical form. When the dissolution medium is a buffer solution, the pH must be adjusted to within ± 0.05 units of the pH value specified in the product monograph. Dissolution time: When a single time is specified in the product monograph, it represents the maximum time within which the minimum quantity, in percentage, of active substance established therein must be dissolved. When more than one time is specified in the monograph, appropriately measured aliquots must be taken at the end of each indicated time. If you work or study in the area of ​​Drug Quality Control, especially in the pharmaceutical sector, this video is essential to understanding how regulations ensure that drugs meet rigorous quality standards. ???? Drug Quality Control Playlist: [ • Drug Quality Control ] ✅ Link to the Brazilian Pharmacopoeia 6th Edition - Volume 1 [https://www.gov.br/anvisa/pt-br/assun...] ✅ Link to the Guide for the Development of Dissolution Methods https://antigo.anvisa.gov.br/document...] ✅ Don't forget to subscribe to the channel and activate the bell for more content on quality control! ???? Follow me on social media for daily updates: [https://www.instagram.com/prof.ricard...] #BrazilianPharmacopoeia #QualityControl #Drugs #Pharmacy #GoodPractices #PharmacyCanal

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