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How to Replace Field Validation into the Plan Of Dissolution

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hello and welcome welcome to this session so in this session i am going to talk about the dissolution how dissolution apparatus can be used very differently for modifying or changing the constituent or the ph of dissolution medium while dissolution run is under progress yes you can do that by using a simple dissolution apparatus like apparatus 1 or apparatus 2 you need not to have the apparatus 3 or apparatus 4 to experience the change into the dissolution medium or ph to your drug product so i am going to explain you a very simple trick right which will definitely blow your mind so if you want to understand that and if you are really curious now how this can be done watch out this video so uh in case of the resolution apparatus one or two it may be let us say ir product or the modified release type product and if you are performing the multi-point dissolution you need to withdraw let us say 10 ml of the sample after every 10 minutes and you may have to again replenish the same amount

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What are the dissolution methods?

Currently, there are seven different types of dissolution apparatus defined in the United States Pharmacopeia (USP)-basket type, paddle type, reciprocating cylinder, flow through cell, paddle over disc, rotating cylinder, and reciprocating disc.

What are the methods of validation for dissolution?

There are two common ways of analyzing dissolution test samples, spectrophotometric (UV) determinations and HPLC. Typically the drug substance UV spectrum is observed to choose the optimum wavelength for analysis.

What are the three main types of dissolution?

3 Types of Dissolution There are 3 main ways a company can be dissolved administratively, voluntarily, and judicially.

What is the method validation?

Method validation is a process that is used to demonstrate the suitability of an analytical method for an intended purpose. Validation procedures have been developed by a variety of industrial committees, regulatory agencies, and standards organizations for purposes of quality control and regulatory compliance.

What is the dissolution method validation FDA?

Dissolution method validation encompasses both the dissolution step (release of the drug substance from the drug product formulation in the dissolution medium) and the analytical finish (the sample handling and analytical method that are used to determine the amount of drug substance dissolved during the dissolution

What are the two dissolution methods?

The most commonly employed dissolution test methods are (1) the basket method (Apparatus 1) and (2) the paddle method (Apparatus 2) (Shah 1989). The basket and the paddle methods are simple, robust, well standardized, and used worldwide.

What are the acceptance criteria for dissolution validation?

A typical acceptance criterion is that the difference in the mean value between the dissolution results at any two conditions using the same strength does not exceed an absolute 10% at time points with less than 85% dissolved and does not exceed 5% for time points above 85%.

Which ICH guideline is used for the validation of dissolution test?

This annex is the result of the Q4B process for the Dissolution Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). It aims to facilitate the recognition of pharmacopoeial dissolution test procedures by regulatory authorities in the ICH regions.

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