European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- __full__ < COMPLETE · 2025 >

For a pharmaceutical professional, mastering is non-negotiable. Whether you are submitting a Section 10.2 dossier to an EU reference member state, performing QC release testing in a GMP lab, or formulating a new generic, every decision must ultimately answer one question: Does this comply with Ph. Eur. Monograph 0478?

must be functional for delivering fractional doses. Compliance requires testing the uniformity of mass for divided parts. www.edqm.eu Special Tablet Categories Key Requirement Effervescent Must disintegrate in water within 5 minutes. Soluble/Dispersible Must disintegrate in water at 15–25°C within 3 minutes. Oral Lyophilisates Disintegrate within 3 minutes in 200 ml of water. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

When the answer is yes, you guarantee not just regulatory approval, but therapeutic success. That is the power of the European Pharmacopoeia. Monograph 0478