European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- May 2026

European Pharmacopoeia (Ph. Eur.) — Monograph: Tablets (0478)

B. Uniformity of Content (Low-dose tablets)

Reference: Ph. Eur. 2.9.6 (or 2.9.40) If a tablet contains less than 2 mg or less than 2% (w/w) of an active substance, Uniformity of Mass is not sufficient. You must perform Uniformity of Content via an assay (usually HPLC) on 10 individual tablets.

• Acceptance Criterion: The acceptance value (AV) must be ≤ 15.0 for 10 tablets (L1 = 15%). No individual tablet falls outside 75-125% of label claim.

4.8. Impurities

• Related substances (degradation products, process impurities) per individual monograph.
• Must comply with general chapter 5.10 (Control of impurities in substances for pharmaceutical use).

5. Storage Conditions

Unless otherwise stated in the individual monograph, tablets must be stored: European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

• Uncoated tablets: in a well-closed container, protected from light and moisture.
• Coated tablets: no special requirement beyond protection from moisture (coating is not a hermetic seal).
• Labeling: “Store in a dry place” if moisture-sensitive.

1. Introduction

The European Pharmacopoeia (Ph. Eur.) is the authoritative standard for the quality control of medicines in Europe. Monograph 0478 "Tablets" is a general monograph, meaning it applies to the entire dosage form category rather than a specific chemical substance. It defines the fundamental standards for the manufacture, identification, testing, and storage of tablets intended for human and veterinary use. European Pharmacopoeia (Ph

This monograph is legally binding in all signatory states of the European Pharmacopoeia Convention and serves as the baseline for marketing authorization applications. Acceptance Criterion: The acceptance value (AV) must be

2.2. Types Covered

• Uncoated tablets
• Film-coated tablets
• Sugar-coated tablets

3. Production Requirements

The monograph sets GMP-related principles for manufacture:

• Uniformity of content must be assured by design (e.g., validated blending and compression steps).
• Friability (for uncoated tablets) is controlled during development to ensure mechanical resistance.
• Coating (if applied) must not impair the tablet’s disintegration or dissolution.
• Excipients must comply with relevant Ph. Eur. monographs and not affect safety or performance.

4. Tests and Acceptance Criteria

All tablets must comply with the following tests unless otherwise stated in an individual monograph.

4. Specialized Tests for Coated & Modified-Release Tablets

Monograph 0478 imposes stricter criteria for non-standard tablets.