USP 788

USP 788 is a standard published by the United States Pharmacopeia (USP) which relates to particulate matter in injections. The USP 788 standard outlines practices and methods used to measured particle size and count in injection liquids. Results are generally expressed in particles per unit volume. The two main methods are the light obscuration test and the microscope particle count test. Each method requires a different type of instrumentation and therefore the standard addresses correct sample preparation and instrument calibration for each instrument. The method which is successful on the greatest variety of samples is the microscope particle count test.

Product Clemex PSFilter includes standard test methods which comply with the requirements of USP 788. Image analysis is used to automate the task of detecting and measuring particles of a certain size range on a 25mm or 47mm membrane filter, under high magnification using an optical microscope. The test methods can also be modified to accommodate the specific needs of the company or the product’sparticularities. The instrument can analyze a single sample or 2 samples at a time.