The determination of residual solvents for all pharmaceutical substances and products has been mandatory since 01/07/2008. This is regulated in the almost harmonised chapters “Residual Solvents” of the European and American Pharmacopoeias (Ph. Eur. chapter 5.4 and USP chapter 467). The ICH regulations also apply for GMP compliant testing.
According to the rules and regulations, testing should basically be performed for all solvents that could be contained within a substance or a product due to their origin or due to manufacturing.
Testing can be omitted only when the presence can be excluded taking into consideration the complete manufacturing or extraction process.
Often, exact production details for all of the chemicals and excipients used are not known. As a result, screening and validation of the content determination is necessary.
Do you ask yourself what differences there still are between the Ph. Eur. and USP despite the extensive harmonisation? Would you like to know whether product-specific validation is necessary for the analysis to conform with GMP? With our technical expertise and experience, we can find the perfect solution for you.