5 Batch Analysis Service

Five-batch analysis is necessary for identifying and quantifying impurities within the production batches of substances to obtain the minimum regulatory closure of 98% w/w required for successful registration. For over 20 years, Charles River chemists have developed expertise in the separation, identification, synthesis and quantification of impurities that may be present as a very small proportion of structurally similar or isometric materials.

5 Batch Analysis refers to the comprehensive testing and evaluation of five separate production batches of a product to ensure consistency, quality, and compliance withspecifications. It is a critical part of product validation and quality assurance in manufacturing.