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What is filter compatibility and why is it so important?
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There are two aspects of filter compatibility that the dissolution scientist should consider...
Sample requirements for a drug filter adsorption study
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To conduct a drug filter adsorption study, typically, a sample representing around 10% to 20% of drug release from the immediate-release dosage form in the dissolution vessel is needed.
What is 'specificity'?
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Specificity is an integral part of analytical method validation and must be performed by carrying out multiple injections to eliminate potential errors that can occur during experimental sequence.
What is 'precision'?
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The degree of deviation between a set of measurements obtained from multiple analysis of the same homogenous sample under the specified conditions expresses the precision of an analytical method.
Why are specificity and precision required with biorelevant media?
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Biorelevant dissolution media contain natural surfactants which can affect chromatographic properties leading to erroneous analytical results.
When is a filter adsorption study necessary?
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Filter adsorption studies should always be conducted before dissolution studies are carried out when a) a new drug is being tested or b) a different biorelevant medium is being used.
Key requirements for filters used in biorelevant dissolution testing
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We recommend the use of glass filters with pre-filters built-in. These filters have excellent efficiency in removing particles and do not leach substances into the biorelevant media.