API Particle Characterisation

Particle characterization is the process of measuring and analyzing the physical properties of particles such as size, shape, and composition. It is used to measure and classify particles in a variety of industrial and scientific applications.

It is used to measure and classify particles in a variety of industrial and scientific applications. Particle morphology (or shape) is an important parameter used to characterize particles in many industries such as pharmaceuticals, food, and cosmetics. Morphology can be used to determine the size and shape of the particles and to identify any defects or irregularities that may exist. Morphology characterization can be done using a variety of methods including light microscopy, scanning electron microscopy, and image analysis.

In addition to morphology and composition, particle characterization can also measure the surface area, density, and refractive index of particles. These parameters can be used to determine the physical and chemical properties of the particles, as well as their interactions with other particles or materials. Knowing these properties can help researchers and engineers design better products and understand the behavior of particles in various applications.

API Particle characterization is useful in the pharmaceutical industry because it allows for a more accurate understanding of the size, shape, and structure of a particular drug compound. This information can be used to ensure that the drug is of consistent quality and can achieve the desired therapeutic effects. Additionally, particle characterization can help identify any potential impurities that could affect the drug's efficacy or safety. By understanding the properties of a drug at the particle level, pharmaceutical companies can make sure they are producing a safe, effective, and consistent product.

The size, shape, surface, and mechanical properties of the particles affect various parameters resulting in changes in dissolution rate, packing density, reaction rate, product appearance, sedimentation, and texture which are crucial for manufacturing purposes. Depending on the relevant subject matter, some or all of them could be important and interrelated as well.

In the pharmaceutical industry, particle size has become one of the key aspects in the development of active pharmaceutical ingredients (APIs) and quality control of solid oral dosage forms. The physicochemical and biopharmaceutical properties of the biologically active substance can be highly affected by crystal size and its distribution (CSD), also called particle size distribution (PSD).

The particle size significantly affects powder flowability, bulk density, hygroscopicity, compatibility, porosity and blend uniformity. These parameters influence every stage of tablet manufacturing (including compression, coating, granulation, and mixing), which affects the effectiveness and shelf life of the drug.

Detailed physicochemical characterization of the API helps manage and mitigate the uncertainty and risks inherent in early-stage drug development.

Methods of particle size distribution analysis

The general monographs in USP for PSD measurement and particle characterization are –

1. USP <776> Optical Microscopy (Particle size, particle shape analysis, Static Image analysis, and Crystallinity characterization).
2. USP <429> Laser Diffraction Measurement of Particle size.

The presence of agglomerated API-API particles can significantly affect the interpretation of the data. Methodologies to identify and account for agglomerates should be evaluated when considering an automated methodology for API particle size characterization.

An important challenge is also the choice of the method that allows proper PSD analysis and solving problems associated with crystal/particle morphology.

One of the most effective techniques for determining and characterizing the size, shape, and volume distributions of particles is the use of image analysis in conjunction with different types of microscopy, which is growing in popularity. The advantage of producing precise information on each particle individually is another benefit of image analysis. Image analysis offers a significant advantage over manual microscopy as it allows large numbers of particles to be measured consistently and accurately.

Image analysis systems today are so powerful, that it is now a straight-forward and relatively short task to develop robust and dependable particle size and shape methods for all sorts of materials.

For effective API Particle characterization, ImageProVison is offering three products that are 21CFR Part 11 compliant.

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