Microbiology Stability Testing Laboratory

Enhanced Stability Testing Overview 

Stability testing is crucial for assessing how the quality of a drug product or substance changes over time under various environmental conditions. Its primary goal is to establish a re-test period for the drug substance or a shelf life for the product, along with recommended storage conditions. 


Types of Stability Testing 

  1. Long Term / Real-time ICH Stability Testing 
  • Conducted at 25°C ± 2°C / 60% RH ± 5% RH or 30°C ± 2°C / 65% RH ± 5% RH for 12 months to simulate actual storage conditions. 
  1. Intermediate Stability Testing 
  • Conducted at 30°C ± 2°C / 65% RH ± 5% RH for 6 months to provide ongoing monitoring. 
  1. Accelerated Stability Testing 
  • Conducted at 40°C ± 2°C / 75% RH ± 5% RH for 6 months to expedite assessment under extreme conditions. 


Key Considerations 

  • Primary Batches: At least three primary batches of the product are tested, manufactured under conditions that simulate the final production process. 
  • Container Closure System: Testing is performed using the actual or simulated packaging intended for storage and distribution. 
  • Specification Testing: Assessments cover attributes susceptible to change during storage, including physical and microbiological characteristics that can impact quality, safety, and efficacy. 
  • Testing Frequency: 
  • Long-term Studies: Initially every 3 months for the first year, every 6 months for the second year, and annually thereafter. 
  • Accelerated Studies: At least three time points, including 0, 3, and 6 months, to monitor rapid changes. 


Why Choose Accugen Labs, Inc.? 

  • Expertise: We bring extensive experience and adherence to regulatory standards (FDA, ICH) to ensure reliable results. 
  • Comprehensive Services: From initial testing to ongoing monitoring, we manage all aspects of stability testing. 
  • Customized Solutions: Our team works closely with clients to tailor testing protocols to meet specific needs and regulatory requirements. 


Get Started Today 

For more information on our stability testing services or to discuss your specific testing needs, contact Accugen Labs, Inc. at: 

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