![]() ![]() ![]() Charge properties: the magnitude of the electrostatic or charge repulsion or that attraction between particles in liquid suspension (Zeta potential) that fundamentally affects stable dispersion.Surface form: specific surface area measured as Sauter Mean Diameter is important in determining bioavailability, reactivity and dissolution and is highly sensitive to the presence of fine particulates in the overall size distribution.Shape: Affecting most of the product and manufacturing variables listed above, as well as abrasive efficiency, texture, and dispersion when combined with agglomerates.Size: the most important single property with key effects on product behaviors such as reactivity, solubility, stability, efficacy in delivery, appearance and ‘feel’ as well as manufacturing considerations such as flow, handling, viscosity and packing density.These basically are determined by chemical composition and the physical properties that shape the behavior of particulates, driving material characteristics such as solubility, reaction, flowability, compressibility, etc.įor manufacturers and developers, the key physical properties of particles include: The exact form of particle characterization will depend on the particle properties that are key to the substance being studied. Whenever the method exceeds original scope.Whenever conditions change for which the method has previously been validated.Revalidation of analytical methods is required: Particle Analytical performs method development and validations for all particle characterization methods and analytical techniques within a portfolio of all pharmaceuticals that also includes controlled substances. Results from method validation can be used to judge the quality, reliability and consistency of analytical results. ![]() Rigorous method development for particle characterization is vital in the overall purposes of studying particles within the pharma business to assure product quality, demonstrate regulatory compliance and achieve superior understanding of products, ingredients and processes to enhance overall performance and competitiveness. The term particle is typically applied to dry powders or granules but can also be understood as droplets, suspensions, emulsions, aerosols or sprays. Meanwhile ‘particle characterization’ describes the size, shape and properties of discrete sub-portions of a substance. Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. ![]()
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