化药

Drug particle size and distribution are key critical quality attributes that govern stability, ocular retention via solution thickness, and therapeutic release characteristics. The laser diffraction technique is an elegant method used to establish the fundamentals of ophthalmic formulations prior to pharmacokinetic or clinical studies. To fulfill the requirements set out by the FDA, our recommendation is the Partica LA-960V2 Particle Size Analyzer.

Process Analytical Technology, or “PAT” is the term given to analytical instruments developed to measure certain attributes of product within the manufacturing process, eliminating, or substantially minimizing the need for sampling for off-line analysis. This approach offers process measurements in-situ with instant access to data, which facilitates rapid decisions during product development and manufacture.