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 testing in multiple tubes is usp general chapter 711 dissolution, the dosage form should be contained within the mesh at the bottom. Q Dissolution testers have a number of configurations with vessel positions in most cases.

We are developing a new disintegration method for this type of dosage form, and we would like to know if we should use disks or if we can use sinkers to prevent the capsules from getting out of the tubes. If automated equipment is used for sampling usp general chapter 711 dissolution the apparatus is modified, validation of the modified apparatus is needed to show that there is no change in the agitation characteristics of the test.

How should a dissolution method be developed for this kind of product? Q We are developing a new product that contains an active substance in the hydrochloride form that is not soluble and forms a precipitate in basic pH.

Apparatus 4 allows a broad range of volumes. Which one should be used, the one in the monograph or the one in the general chapter?

Usp general chapter 711 dissolution 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?

For this reason, granules, usp general chapter 711 dissolution, and matrix or layered tablets are typical samples. Shaft and basket components of the stirring element are fabricated of stainless steel, type or equivalent, to the specifications shown in Figure 1. Perform the analysis as directed in the individual monograph. The vertical center line of the blade passes through the axis of the shaft so that the bottom of the blade is flush with the bottom of the shaft.

Make any necessary correction. Usp general chapter 711 dissolution is destructive of the sample. 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.

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Questions and Answers May 2017

usp general chapter 711 dissolution A Peak vessels are not described in the dissolution general chapter in part because their geometry has not been stan-dardized. Heat the medium, while stirring gently, to about 41immediately filter under vacuum using a filter having a porosity of 0. In contrast to sample preparation in an assay, dissolution test conditions are selected based on their discriminatory power and not on their ability to extract as much of the active ingredient as possible.

A The dissolution test evaluates the rate of drug dissolved over time. Continue testing through the three stages unless the results conform at either Usp general chapter 711 dissolution 1 or S 2.

The paddle conforms to the specifications shown in Figure 2. Keep the vessel covered for the duration of the test, and verify the temperature of the mixture under test at suitable times. This will be very important genera doing any type of dissolution profiles comparison and in developing an in vivo-in vitro correlation. Q We have a product that is a suspension with two active substances, one of which has high solubility in water.

The text does not address dissolution profiles. Shear is at a minimal level in the region below the tip of the paddle shaft. For a six-position up assembly, 2X would be 12 tablets tested. The vessel is cylindrical, with a hemispherical bottom and with one of the following dimensions usp general chapter 711 dissolution capacities: Acceptance Table for a Pooled Sample.

In the closed-loop configuration, a minimal amount of medium can be used. Vessels and baskets or paddles are provided for each position. With poorly soluble drugs, individual products may have different testing conditions based on the physical characteristics of usp general chapter 711 dissolution drug substance and on the release mechanism of the dosage form.

Some USP monographs were revised to provide both options, single and pooled sampling. Q We are performing the dissolution test using eissolution sample size of 5 mL of an oral suspension and are not sure how this volume will affect 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 usp general chapter 711 dissolution as follows. USP Apparatus 1 basket2 paddleand 3 reciprocating cylinder have different hydrodynamics.


The vessel is partially immersed in a suitable water bath of any convenient size or placed in a heating jacket. Other validated deaeration techniques for removal of dissolved gases may be used. Us; it necessary to develop a dissolution test for both active substances or only for the poorly soluble one?

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. The instructions stated in the chapter can be adapted for this particular application. Determine the average amount of the active ingredient dissolved in the pooled sample.

Therefore, floating capsules should not be able to escape. Therefore, it is recommended that sampling during any type of dissolution test evaluation usp general chapter 711 dissolution done within the requirements stated chapfer the USP general chapters.

We are conducting some evaluations using fasted-state simulated intestinal fluid pH 6. Q In some disintegration chaptdr for delayed-release capsules, the use of disks is recommended.

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It has local action on the GI and negligible systemic availability. That being the case, it should have some solubility within the physiologic pH range, roughly pH 1—7. 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.

A Sinkers can be used if the dosage form tablet or capsule floats usp general chapter 711 dissolution if it sticks to the vessel walls. Q The time point in our dissolution procedure is 30 min. It is up to your lab to decide, usp general chapter 711 dissolution 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.

For the two-stage procedure, if the criteria after stage 1 are not met, six additional tablets are tested. A new analyst ran the method without the sinkers and justified that the method did not require them.