: Including prolonged-release and delayed-release (gastro-resistant) forms to control where or when the drug is absorbed. Reference Standards
This guide is for informational purposes only. Always refer to the official current edition of the European Pharmacopoeia for legally binding requirements. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
Based on FDA and EMA warning letters citing Ph. Eur. 0478 (or equivalent national requirements), here are the top 5 failures: here are the top 5 failures: