Sampling and preparation techniques key to success in meeting new requirement for particulate analysis in SVPs

Effective 1 April 2005, Version 5.1 of the European Pharmacopoeia requires that dosage forms ofparenterals less than 100ml be inspected for liquidborne particles using an optical particle counteror, in certain case, an optical microscope. Previously the EP required particulate analysis only fordosage forms greater than 100ml. The test procedure for Small Volume Parenterals (SVPs) incontainers under 25ml has been in place within the EP for a number of years [Section 2.9.19, Test1.B] but until Edition 5.1 testing was not required for dosage forms equal to or less than 100ml. Thisrevision brings testing of European parenteral products more closely into harmony with the existingAmerican USP, Japanese JP and Korean KP regulations.