Method Development and Method Validation for Particle Size

The size, distribution and shape of the particle size will affect the quality of drugs, such as dissolution, bioavailability, content uniformity and stability, and ultimately affect the safety, effectiveness and quality control of drugs. In the whole life cycle of drug development and production, the measurement of particle size has become a very important basic work in drug research. The improvement of particle size detection is of great significance for the assurance of pharmaceutical quality, and the influence of particle size on product quality should be included in the risk assessment system.

Particle Size Research Method

The control standard for the particle size and distribution of the drug can be formulated according to the comprehensive selection of the type of drug, route of administration and clinical needs. Due to the importance of particle size control, multiple methods are recommended for particle size analysis, and changes in particle size micro-morphology are investigated during stability studies. Accurate control of particle size and distribution is necessary to ensure the quality and stability of drugs. Appropriate determination methods should be established to study the particle size of drugs, and complete methodological validation and optimization should be carried out. Particle size detection is usually measured by dynamic light scattering (DLS), in addition to sieving method and microscope method.

Method Validation

To define the typical analytical parameters that should be considered when a validation of an analytical method is performed. To describe the way in which a method is validated according to these parameters. In order to prove the analytical capability of a method that assesses physical properties of powder or other solid materials, the following main analytical parameters are relevant:

Representative sample, specificity, durability, repeatability, linearity, intermediate precision, reproducibility, refractive index inspection.

Our Services

CD Formulation provides the most advanced variety of particle size analyzers. Our expert team develops a detection method suitable for your sample according to the nature and sample size of your sample, which can detect your sample quickly and efficiently, and provide a complete analysis method and verification report.

Sample quantity requirements for particle size detection

• Sampling should be representative.
• Powder sample: sample quantity is not less than 5 g.
• Liquid sample: the sample volume of lower concentration is about 5 mL, and the sample volume of high concentration is about 2 mL.

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Reference

1. USP 34<429>: Optical diffraction test of particle size, 2011.