Stability and Photostability Studies

Energon Labs can support our client for execution of stability studies through well designed stability protocols, coordination for stability program, timely pull out and analysis of stability samples. We provide stability testing and storage services to the pharmaceutical industry. Our facility conducts ICH stability studies using methods supplied by clients, compendial methods, or internally validated procedures. We test a wide range of drug formulations, including sterile injectables, tablets, capsules, non-sterile liquids, transdermal products, aerosols, and medical device combination products.

 

Our services cover both long and short-term (accelerated) stability programs, as well as photo stability studies for both R&D and commercial products. Our stability storage chambers are meticulously mapped and continuously monitored by a validated system.

  • Stability Testing Services
      • Formulation Development and Optimization Stability
      • Real -Time Stability
      • Accelerated Stability
      • Freeze thaw Study
      • Photo stability testing
      • Commercial batch stability studies
      • R&D batch exploratory stability studies
  • Purpose

    • Evaluation Over Time: Stability studies assess the chemical, physical, and microbiological characteristics of a product over time under various conditions.
  • Storage & Conditions
  • Duration of Studies

    • Long-Term and Accelerated: Long-term studies simulate the expected storage conditions over the intended shelf life, while accelerated studies use elevated conditions to predict long-term stability more quickly.
  • ICH Guidelines

    • ICH Q1A and Q1B: Provide guidelines for stability testing, including the design of stability studies and the evaluation of stability data.

      In summary, both photostability studies and stability studies are crucial for ensuring the quality and safety of pharmaceutical products. These studies help manufacturers understand how products may change over time due to exposure to light or other environmental conditions, enabling them to establish appropriate storage and handling recommendations and meet regulatory requirements.
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