Stability Testing for AYUSH Products
Stability testing is crucial for AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy) products to ensure their safety, efficacy, and quality over their shelf life. This process helps determine how environmental factors such as temperature, humidity, and light affect the product.
Tamilnadu test House provides the stability study services to determine the shelf life and storage conditions.
Tamilnadu conducts the stability study as below:
Study |
Storage condition |
Duration |
Long-Term Stability |
25°C ± 2°C, 60% RH ± 5% RH |
Minimum 12 months |
Accelerated Stability |
40°C ± 2°C, 75% RH ± 5% RH |
6 months |
Intermediate Stability |
30°C ± 2°C, 65% RH ± 5% |
Case-specific |
Parameters for Stability Testing
Category Tests Performed
Physical: Appearance, color, texture, phase separation, weight variation
Chemical: Active ingredient stability, pH, moisture content, degradation products
Microbial: Total viable count, yeast & mold, pathogenic bacteria (E. coli, Salmonella, etc.)
Therapeutic: Potency of active ingredients (e.g., alkaloids, Flavonoids)
Packaging: Interaction with packaging materials, leakage, integrity
Guidelines & Regulatory Framework
1. AYUSH Ministry Guidelines (India)
2. Schedule T of the Drugs & Cosmetics Act, 1940 (for Good Manufacturing Practices – GMP)
3. WHO Guidelines for Stability Testing of Herbal Medicines
4. ICH Guidelines (where applicable)
Stability testing is essential for AYUSH product standardization and global acceptance. TNTH expert team ensure the consumer safety and product reliability with proper scientific validation which gives higher credibility and regulatory compliance to the traditional medicines.