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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If so, should we use mL of dissolution medium? From that data, you might discover a possible dissolution medium.

Questions and Answers May 2017

The text does not address dissolution usp general chapter 711 dissolution. That being the case, it should have some solubility within the physiologic pH range, roughly pH 1—7. Q We received an inspection by the local regulatory agency, and the inspectors recommended that we do mechanical qualification before each dissolution test.

It has a limitation that not more than mL of dissolution medium can be used in each tube, but allows testing over six tubes.

The two-stage procedure allows a stop at only 1X if the criteria are met. William Brown and Margareth Marques The following questions have been submitted by readers of Dissolution Technologies.

Usp general chapter 711 dissolution are working with a fixed combination product, and one of the drug substances usp general chapter 711 dissolution dissokution low solubility in aqueous solvents. 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.

Q We have a dissolution method for a capsule that does not mention the use of sinkers. Its sides are flanged at the top. For the six-position assembly, that would be uzp only six tablets are tested one tablet in each vessel. No part of the assembly, including the environment in which the assembly is placed, contributes significant motion, agitation, or dissolutlon beyond that due to the smoothly rotating stirring element.


The large volume available in the open-loop configuration makes this apparatus useful in testing extend-ed-release implants or products with poorly soluble drugs. In usp general chapter 711 dissolution closed-loop configuration, a minimal amount of medium can be used.

Some level of physiological relevance as well as discriminatory power are important aspects of a dissolu-tion method.

August Questions and Answers

For example, the recommended dissolution method in the FDA usp general chapter 711 dissolution for posaconazole delayed-release tablets indicates the use of 0. To establish any kind of correlation, it is necessary to do computer modeling of the hydrodynamics of each apparatus and confirm by dissolution testing an array of different products. The vertical center line of the blade passes dissolytion the axis of the shaft so that the bottom of usp general chapter 711 dissolution blade is flush with the bottom of the shaft.

However, for the later stages of the test, the average of the units tested must not be less than Q.

Do you have any suggestions? The vessel is cylindrical, with a hemispherical bottom and with one of the following dimensions and capacities: We are developing a new disintegration method for this type of dosage form, and we would like to know if we should use disks usp general chapter 711 dissolution disslution we can use sinkers to prevent the capsules from getting out of the tubes.

Questions and Answers May

The information obtained generla dissolution testing using simulated biological fluids should be shared with the formulation development team to help usp general chapter 711 dissolution seek formulation alternatives to prevent or minimize the precipitation that may occur in vivo. Chaper Qvalue is a variable that is substituted into the acceptance criterion given in Acceptance Table 1.

If the Dissolution Medium is a buffered solution, adjust the solution so that its pH is within 0. A The use of dissolution media that simulate biological fluids is usp general chapter 711 dissolution useful tool to gather more information about how the dosage form could perform in vivo.


As the size and shape of the sinker may have a big impact in the dissolution profile, it has to be selected in a case-by-case approach. Usp general chapter 711 dissolution The sampling should be done with the paddles rotating. Q What are the effects on the results when the dos-age form does not drop to the center of the vessel in the paddle apparatus?

Therefore, it is recommended that sampling during any type of dissolution test evaluation be done within the requirements stated in the USP general chapters.

If automated equipment is used for sampling and the apparatus is usp general chapter 711 dissolution, validation of the ussp apparatus is needed to show that there is no change egneral the agitation genedal of the test. If dissolution apparatus with six and eight vessels are being evaluated, should the test be carried out with two different sets of tablets?

Q According to the certificate that accompanies USP Prednisone Tablets RS, if the equipment has fewer than 12 positions, step generak should be repeated with usp general chapter 711 dissolution additional set of tablets. Start by evaluating the solubility over that range. In such cases, dissolved gases should be removed prior to testing. A The drug will likely have to be in solution to provide pharmacological action even though it is not absorbed into the systemic circulation.

The test calls for mL of medium. Why should a dissolution method be developed? The same logic should be applied to the other time points and to level L3.