Product Stability Studies

1. STUBILITY STUDIES TYPES

ii. Real-Time Stability Studies

• Temperature & Humidity Testing

ii. Accelerated Stability Studies

• Temperature and Humidity Stability Testing
• Photo-stability Studies

• • UV Light Stability Studies
  • Visible Light Stability Studies

iii. Intermediate Condition

iv. Refrigerated Conditions (Non-frosted)

v. Frozen Conditions (Frosted)

2. STABILITY DETERMINATIONS – In different environmental conditions

• Determination of shelf-life (Best Before Dates, Re-test Dates and Expiry Dates)
• Determination of appropriate storage conditions
• Determination of appropriate packaging materials
• Determination of degradation products
• Determination of decomposition of plastic products and plastic packaging materials-

( Point of brittleness, discoloration/yellowing, deformation temperature, etc)

3. STABILITY TESTING CONDITIONS

Conditions according to ICH guidelines and WHO zoning specifications:

• Zone I :  Temperate Climates and Countries
• Zone II : Subtropical Climates and Countries ( e.g., Zambia, Congo, Eqypt, South Africa, Namibia, etc)

• Zone III : Hot and Dry Climates and Countries, Mediterranean Climates ( Chad, Niger, Middle East, etc)

• Zone IV –A :   Hot and  Humid Countries(e.g., Burkina Faso, Liberia, Niger, Mali, Senegal, etc)
• Zone IV –B : Hot and very Humid Countries (e.g., Ghana, Sierra Leone, Nigeria, etc)
• Refrigerated Conditions
• Frozen Conditions

4. TARGET PRODUCTS 

• Pharmaceutical products
• Food products 
• Herbal products
• “Re-constitute Before Use” formulations of any of the above products(Stability after re-constitution)
• Multiple-use packaged products: In-use stability studies of multiple-use products  after opening the container

• Household Chemicals
• Plastic Products and Plastic Packaging Materials
• Cosmetics