Package Stability Testing Services

ANALYZETESTING LABS offers a full range of stability testing services, including long-term, intermediate, accelerated, and photostability testing based on ICH guidelines. Our programs are customized to meet product type, regulatory expectations, and market requirements.

Stability testing services include, but are not limited to:

• Active Ingredient Assays (HPLC, GC, and other analytical methods)
  
  
• Antimicrobial Effectiveness / Preservative Efficacy Testing (PET)
  
  
• Microbial Limits Testing
  
  
• Moisture and Solids
  
  
• BP, EP, JP, and USP Monograph Testing
  
  
• Color
  
  
• Odor
  
  
• Appearance
  
  
• pH
  
  
• Specific Gravity
  
  
• Viscosity
  
  
• Package Compatibility
  
  
• Hardness
  
  
• Weight Loss / Gain
  
  
• Period-After-Opening (PAO)
  
  
• Freeze / Thaw Analysis
  
  
• Ambient and Above-Ambient Testing
  
  
• Photostability
  
  

UV Exposure Studies

Our stability testing laboratories maintain a wide range of ICH-compliant storage conditions to support long-term, intermediate, accelerated, and stress testing studies.

Available storage conditions include:

• 25°C ± 2°C / 60% RH ± 5% RH
  
  
• 30°C ± 2°C / 65% RH ± 5% RH
  
  
• 30°C ± 2°C / 75% RH ± 5% RH
  
  
• 40°C ± 2°C / 75% RH ± 5% RH
  
  
• 45°C ± 2°C
  
  
• 50°C ± 2°C
  
  
• 60°C ± 2°C
  
  
• 5°C ± 2°C (Refrigerated)
  
  
• Freeze / Thaw (-10°C to -20°C)
  
  
• Ambient / Above Ambient
  
  
• UV Exposure
  
  
• Photostability per ICH Q1B (Option 2: 1.2 million lux-hours / 200 W/m²)
  
  

• ANALYZETESTING LABS manages stability studies from start to finish to ensure consistency, traceability, and regulatory alignment.

  Our stability testing process includes:

  • Pulling samples at prescribed intervals (e.g. 3, 6, 9, 12 months, and beyond)
    
    
  • Performing required physical/organoleptic, microbiological, chemistry/analytical, and other testing
    
    
  • Providing best-practice guidance, detailed protocols, and official stability trending reports
    
    

  While product degradation cannot be accelerated beyond scientific limits, we focus on efficient testing workflows and timely reporting following each scheduled pull point.

• Designing a compliant stability testing protocol can be complex due to varying regulatory expectations across product categories and markets. ANALYZETESTING LABS provides expert guidance to support protocol design and regulatory decision-making.

  Our scientific team offers consulting and recommendations based on extensive knowledge of ICH, FDA, USP, ISO, and other regulatory frameworks, ensuring your stability program generates the data needed to support quality, safety, and compliance.

• Our stability testing reports are designed to be clear, visual, and easy to understand, while still meeting regulatory and technical requirements. Clients receive structured data, trend analysis, and conclusions that support confident product and regulatory decisions.

  In addition to final reports, we support clients throughout the entire lifecycle of their stability studies.

• At ANALYZETESTING LABS, clients receive direct access to the scientists managing their stability testing programs.

  This includes:

  • 1:1 interaction with stability testing scientists
    
    
  • Expert consultation in the event of out-of-specification (OOS) results
    
    
  • Fast, responsive communication
    
    
  • Clear answers to technical and regulatory questions