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In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles. [1]
Both tests should accurately measure the purity of the sample. Quantitative tests of either the active moiety or other components of a sample can be conducted through assay procedures. Other analytical procedures such as dissolution testing or particle size determination may also need to be validated and are equally important.
In pharmaceutics, sink condition is a term mostly related to the dissolution testing procedure.. It means using a sheer volume of solvent, usually about 5 to 10 times greater than the volume present in the saturated solution of the targeted chemical (often the API, and sometimes the excipients) contained in the dosage form being tested.
Acceptance testing of an aircraft catapult Six of the primary mirrors of the James Webb Space Telescope being prepared for acceptance testing. In engineering and its various subdisciplines, acceptance testing is a test conducted to determine if the requirements of a specification or contract are met.
Lipinski's rule of five, also known as Pfizer's rule of five or simply the rule of five (RO5), is a rule of thumb to evaluate druglikeness or determine if a chemical compound with a certain pharmacological or biological activity has chemical properties and physical properties that would likely make it an orally active drug in humans.
In general, acceptance sampling is employed when one or several of the following hold: [2] testing is destructive; the cost of 100% inspection is very high; and; 100% inspection takes too long. A wide variety of acceptance sampling plans is available. For example, multiple sampling plans use more than two samples to reach a conclusion.
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
In analytical chemistry, sample preparation (working-up) refers to the ways in which a sample is treated prior to its analyses. Preparation is a very important step in most analytical techniques, because the techniques are often not responsive to the analyte in its in-situ form, or the results are distorted by interfering species.