Moisture Testing and Its Impact on ODF & Tablet Stability

Introduction
Throughout the lifecycle of solid dosage forms—during production, transportation, and storage—moisture content plays a critical role in determining product stability. Excess moisture may cause softening, deformation, or microbial risks, while insufficient moisture can lead to brittleness, compromising appearance and dosage uniformity. Moisture testing is therefore essential not only for in-process quality control, but also for long-term stability assurance.

1. The Link Between Moisture and Storage Stability

• Sensitivity to Temperature and Humidity: ODFs and tablets are prone to moisture uptake and degradation in high-humidity environments.
• Packaging Compatibility: Moisture barrier performance varies between packaging types such as foil, bottles, or pouches—making moisture testing vital for validation.
• Shelf-Life Evaluation: High or fluctuating moisture levels can directly shorten product shelf life and impact regulatory acceptance.

2. Common Challenges in the Industry

• Single-Point Testing: Many manufacturers only test moisture at the time of release, ignoring dynamic changes during storage.
• Packaging Neglect: Moisture validation often focuses on the final product, omitting packaging and simulated storage condition testing.
• Time-Consuming Methods: Traditional oven-drying techniques are inefficient and unsuited for fast-paced batch environments.

3. Industry Trends

• Rapid Moisture Analysis: Electronic moisture analyzers are increasingly replacing traditional oven methods for higher efficiency.
• Expanded Stability Studies: Companies are aligning with ICH guidelines to integrate moisture testing into accelerated and long-term studies.
• End-to-End Quality Control: Moisture analysis is now being extended to raw materials and intermediates, not just final products.

4. HUANGHAI’s Moisture Testing Solutions

• Our HY-310 Electronic Moisture Analyzer supports testing of ODF films, tablets, and powders.
• Offers fast detection, easy operation, and suitability for large-scale quality control and stability trials.
• Delivers high accuracy in compliance with pharmacopoeial standards, minimizing risks during registration and export.

👉 Recommended Product:
HY-310 Electronic Moisture Analyzer

Conclusion

Moisture testing is a small but vital step in ensuring the long-term quality of solid dosage forms. By adopting fast and reliable moisture testing technologies, pharmaceutical and supplement manufacturers can effectively predict shelf-life, mitigate regulatory risks, and enhance market competitiveness.