[Granulation / Blending] ──> [In-Process Mechanical Testing] ──> [Microbiological & Divisibility Quality Checks]
: Single-layer or multi-layer structures resulting from a single compression of particles. No subsequent coating is applied. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
Intended to be dissolved or dispersed in water before intake. While not always a specific limit in the
While not always a specific limit in the monograph, hardness is a critical in-process control (IPC). The tablet must be hard enough to handle but soft enough to disintegrate/dissolve. safety and identity
Required to disintegrate within 5 minutes in cold water. 3. Dissolution
Roche Friabilator (drum rotating at 25 RPM). Procedure: Dedust 10 tablets. Weigh exactly. Rotate for 100 revolutions (4 minutes). Dedust and reweigh. Acceptance criteria:
When the laboratory’s fluorescent lights hummed to life at 07:00, Dr. Elena Varga already had the monograph open on her screen. It was the 0478 monograph — Tablets — the quiet scaffolding behind millions of doses crossing borders, dispensed in hospitals, bought at neighborhood pharmacies. To most, it was an obscure file name in the European Pharmacopoeia; to Elena it was a promise: consistent quality, safety and identity, written in a language of limits and methods.