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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How should a dissolution method be developed for this kind of product? A The decision to include the volume of the sample in the final volume of dissolution medium in the vessel has to be based on experimental data obtained with the samples under evaluation.

Make any necessary correction.

The dissolution test should be discriminatory for dissolutin critical quality attributes of the product. Q My question relates to the use of surfactants in the dissolution medium for poorly water-soluble drugs.

Questions and Answers May 2017

A The sampling should be done with the paddles chapteer. It has a limitation that not more than mL of dissolution medium can be used in each tube, but allows testing over six tubes. A The USP general chapters related to dissolution and drug release usp general chapter 711 dissolution not specify when to do the temperature check. 171 When performing the dissolution test as per the USP monograph for Oxycodone and Acetaminophen Tablets, is it expected that the analyst will prepare and analyze only the pooled sample?

The rotating paddles mix the cyapter contents and are a condition of the test procedure. 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. However, for the later stages of gsneral test, the average of the units tested must not be less than Q. Therefore, 7711 recommendation is to check the temperature of usp general chapter 711 dissolution medium in the vessel after the last sample is taken.

A new analyst ran the method without the sinkers and justified that the method did not require them. The shaft is positioned so that its axis is not more than 2 mm at any point from the vertical axis of the vessel and rotates smoothly without significant wobble.

In most cases, the problem of formation of a cone of material at the bottom of the vessel can be eliminated or reduced by increasing the speed of the paddle. Individual dosage unit results are more useful for any other purpose dissolution profiles, investigations, etc. Why should a dissolution method be developed? For media cissolution a pH of 6. Unless otherwise specified in the individual diesolution, use mesh cloth. Which controls should be done before running each dissolution test?

William Brown and Margareth Marques The following questions have been submitted by readers of Dissolution Technologies. A basket having a gold coating 0. The text does not address dissolution profiles.

Every usp general chapter 711 dissolution should usp general chapter 711 dissolution made to initiate the test in a standard fashion. Q Chapterr have a dissolution method for a capsule that does not mention the use of sinkers.

The two-stage procedure allows a stop at only 1X if the criteria are met.

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The same logic should be applied to the other time points and to level L3. Perform the analysis as directed in the individual monograph. In such cases, dissolved gases should be removed prior to testing. Do we need to take usp general chapter 711 dissolution account the 5 mL of sample? If the Dissolution Medium is a buffered solution, adjust the solution so that its pH is within 0. Q When dissolution testing is usp general chapter 711 dissolution in my lab, the temperature of the water bath is measured chaptwr to the introduction of the samples and again before the final sample is pulled.

The shaft is positioned so that its axis is not more than 2 mm at any point from the vertical axis of the vessel and rotates smoothly and without significant wobble. We are working with a fixed combination product, and one of the drug substances has very low solubility in aqueous solvents. Would it ever be considered appropriate to analyze only individual vessels in lieu of a yeneral sample as specified in a monograph? The use of these types of dissolution media is not mandatory and does not have application in routine quality control.

For a six-position test assembly, 2X would be 12 tablets tested. It is diseolution to your lab to decide, but keep in mind that every time you introduce a probe in the dissolution vessel, the hydrodynamics inside the vessel is perturbed, and this perturbation may or may not interfere in the dissolution results.

From that data, you might discover a possible dissolution medium. However, if the testing is performed for other purposes, sampling will depend on the purpose of the test.

Some drugs rely on naturally occurring surfactants to dissolve in the GI tract. The Qvalue is a variable usp general chapter 711 dissolution is substituted into the disdolution criterion given in Acceptance Table 1. Q We are performing the dissolktion test using a sample size of 5 mL of an oral suspension and are not sure how this volume will usp general chapter 711 dissolution the final volume of dissolution medium. For hard or soft gelatin capsules and gelatin-coated tablets that do not conform to the Dissolution specification, repeat the test as follows.

Dussolution 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. The medium can be modified in each tube.

Questions and Answers May

A The drug will likely have to be in solution to provide pharmacological action even though it is djssolution usp general chapter 711 dissolution into the systemic circulation. You should be aware that the pooled dissolution procedure should produce the same result that would be obtained by mathematically averaging the results from individual vessels. Q According to the certificate that accompanies Usp general chapter 711 dissolution Prednisone Tablets RS, if the equipment has fewer than 12 positions, step 1 should be repeated with an didsolution set of tablets.

Is it necessary to develop a dissolution test for both active substances or only for the poorly soluble one? If testing in multiple tubes is done, the dosage form should be contained within the mesh at the bottom.

Apparatus that permits observation of the specimen and stirring element during the test is preferable. The test calls for mL of medium.