5 Jun 〈〉 DISSOLUTION This general chapter is harmonized with the correspond- tional USP text, and therefore not part of the harmonized. General Chapters DISSOLUTION usp – Download as PDF File .pdf), Text File .txt) or view presentation slides online. DISSOLUTION This general. How should the level L2 from Acceptance Table 2 in the USP General Chapter > Dissolution be applied for this time point? A To apply the levels L2 and L3.

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Q My question relates to the use of surfactants in the dissolution medium for poorly water-soluble drugs. A fitted cover may be used to retard evaporation 2. No part of the assembly, including the environment in which the assembly is placed, contributes significant motion, agitation, or vibration beyond that due to the smoothly rotating stirring element. Shear is at a minimal level in the region below the tip of the paddle shaft. However, for the later stages usp general chapter 711 dissolution the test, the average of the units tested must not be less than Q.

If automated equipment is used for sampling and the apparatus is modified, validation of the modified apparatus is needed to show that there is no change in 711 agitation characteristics of the test. Experimental results have shown that tablets falling to rest away from the vessel center may have higher dissolution results than tablets at the vessel center. Some drugs rely on naturally occurring surfactants to dissolve in the GI tract. It us up to your lab to decide, but keep in mind that every time you introduce a probe in the dissolution vessel, the hydrodynamics inside generla vessel is perturbed, and this perturbation may or may not interfere in the dissolution results.

The dosage dissolutioh is placed in a dry basket at the beginning of each test.

usp general chapter 711 dissolution Q The regulatory agency asked our company to develop a dissolution test for a product that contains an active substance that is nearly insoluble in water.

A The cahpter dissolution procedure is the official means to determine conformance. The Qvalue is a variable that is substituted into the acceptance criterion given in Acceptance Table 1.

Questions and Answers May 2017

Combine equal volumes of the filtered solutions of the six or twelve individual specimens withdrawn, and use the pooled sample as the test solution. Brown, Scientist Expert Committee: The instructions stated in the chapter can be adapted for this particular application.


A You will need to verify experimentally how the highly soluble drug substance is affected by the formulation by do-ing a dissolution profile along with the other drug substance.

In the closed-loop configuration, a minimal amount of medium can be used. Usl the time interval specified, or at each of the times stated, withdraw a specimen from a zone midway between the surface of the Dissolution Medium and the top of the rotating basket or blade, not less than usp general chapter 711 dissolution cm from the vessel wall.

Usp general chapter 711 dissolution test calls for mL of medium.

Accuracy may not be the most appropriate term 71 the dissolutioj of usp general chapter 711 dissolution rotation speed of a dissolution method. In such cases, dissolved gases dissoution be removed prior to testing. Of the types of apparatus described herein, use the one specified in the individual monograph. However, if the testing is performed for other purposes, sampling will depend on the purpose of the test. It is destructive of the sample.

A basket having a gold coating 0. The same logic should be applied to the chaptsr time points and to level L3. If dissolution at a reasonable level cannot be achieved, then it is possible that the addition of a surfactant to the medium may be needed. Where the label states that an article is enteric-coated, and a dissolution or disintegration test that does not specifically state that it is to be applied to enteric-coated articles is included in the individual monograph, the test for Delayed-Release Articles under Drug Release is applied unless otherwise specified in the individual monograph.

Depending on the usp general chapter 711 dissolution of the two active substances in the dissolution test, you will geeneral if you are going to control the dissolution of both of them or only the poorly soluble dlssolution. A Peak vessels are not described in the dissolution general usp general chapter 711 dissolution in part because their geometry has not been stan-dardized.

With jsp soluble drugs, individual products yeneral have different testing conditions based on the physical characteristics of the drug substance and on the release mechanism of the dosage form. Q Are there any guidelines on the use of peak vessels? If testing in multiple tubes is done, the dosage form should be contained within the mesh at the bottom. The medium can be modified in each tube.


Would it ever be considered appropriate to analyze only individual vessels in lieu of a pooled sample as specified in a monograph? The vertical center line of the blade passes through the axis of usp general chapter 711 dissolution shaft so that the bottom of the blade is flush with the bottom of the shaft.

Note that following the pooled sampling procedure as written will lose any information about the individual units tested. Can we increase this rotation speed to improve the accuracy of the dissolution method? Is it mandatory to use sinkers in the dissolution testing of capsules?

This will be very important when doing any type of dissolution profiles comparison and in developing an in vivo-in vitro correlation. The use of basket or paddle usp general chapter 711 dissolution and — mL are typical and would be a good starting point. The need to use sinkers should be evaluated during method development.

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The description of the setup of the disintegration test, if followed, will prevent the immersion of the tops of the tubes. Usp general chapter 711 dissolution Brown and Margareth Marques The following questions have been submitted by readers of Dissolution Technologies. Acceptance Table 3 gives general criteria for acid resistance testing. The open-loop configuration allows the use of an unlimited volume of fresh medium. A new analyst ran the method without the sinkers and justified that the method did not require them.

If the product contains more than one active ingredient, depending on the solubility of each one of them, separate dissolution tests with different test conditions may be needed.

At the end of the process with dissolution data in hand, you will still need to justify the conditions chosen. Therefore, the dosage form should fall to rest at the center of the vessel bottom.