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There are three typical situations where dissolution testing plays a vital role: (i) formulation and optimization decisions: during product development, for products where dissolution performance is a critical quality attribute, both the product formulation and the manufacturing process are optimized based on achieving specific dissolution targets.
The integral heat of dissolution is defined as a process of obtaining a certain amount of solution with a final concentration. The enthalpy change in this process, normalized by the mole number of solute, is evaluated as the molar integral heat of dissolution. Mathematically, the molar integral heat of dissolution is denoted as
Loss on ignition (LOI) is a test used in inorganic analytical chemistry and soil science, particularly in the analysis of minerals and the chemical makeup of soil. It consists of strongly heating a sample of the material at a specified temperature, allowing volatile substances to escape, until its mass ceases to change. This may be done in air ...
In a dissolution process, a solute is changed from a pure phase—solid, liquid, or gas—to a solution phase. If the pure phase of the solute is a solid or gas (presuming the solvent itself is liquid), the process can be seen in two stages: the phase change into a liquid, and the mixing of liquids. The dissolution process is generally ...
Calorimetry requires that a reference material that changes temperature have known definite thermal constitutive properties. The classical rule, recognized by Clausius and Kelvin, is that the pressure exerted by the calorimetric material is fully and rapidly determined solely by its temperature and volume; this rule is for changes that do not involve phase change, such as melting of ice.
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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.
Gravimetric analysis describes a set of methods used in analytical chemistry for the quantitative determination of an analyte (the ion being analyzed) based on its mass. The principle of this type of analysis is that once an ion's mass has been determined as a unique compound, that known measurement can then be used to determine the same analyte's mass in a mixture, as long as the relative ...