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Stability Studies

Anecto offers extensive stability testing and stability storage services as described in the International Conference on Harmonisation (ICH) guideline Q1A (R2). 

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Ensuring the long term efficacy of pharmaceutical products is an essential element in the development process of a drug or medical device containing or coated with a drug. Ensuring that the efficacy of the product remains for a sustained period of time in various environments and circumstances is essential to guarantee market approval and release. Anecto’s stability capability makes this possible.

What are stability studies?

Stability studies are necessary throughout the development process and are used to ascertain how specific environmental conditions and temperatures affect the efficacy /potency of medicinal products or pharmaceutical ingredients over a specific period of time. They are an essential part of bringing a drug or a medical device containing or coated with a drug to market. Stability Studies must be carried out at various stages of the development process. All Anecto stability tests are in compliance with ICH guidelines.

Anecto’s capabilities
Anecto’s chambers are specifically designed to carry out either large scale testing or specific early stage studies on pharmaceutical ingredients and medicinal products. Anecto can simulate the temperature and humidity climatic zones identified for worldwide stability testing, which typically cover

  • Temperate
  • Subtropical/Mediterranean, with possible high humidity
  • Hot/dry
    • Hot/humid
    • Hot/very humid
  • Cold
    • Refrigerated
    • Frozen

These climates cover all areas of the globe as can be seen below:

Climate zones

The ranges of Anecto’s temperature and humidity capabilities are as follows as per the ICH guidelines:

  • 21°C / 45% RH
  • 25°C / 60% RH
  • 30°C / 35% RH
  • 30°C / 70% RH

These are relatively narrow ranges, however the equipment is capable of working from -80°C up to + 120°C and relative humidity levels from ≈10% RH to 95% RH and are capable of meeting Customer specific conditions.

Stability Study Testing Services

  • Protocol Development
  • Support in designing studies for real time and stress tests
  • Development and validation of “stability indicating methods“
  • Examination of stability-relevant parameters
  • Storage and management of the stability samples

Storage

  • Each stability chamber operates independently with its own temperature and, where applicable, humidity controls.
  • All storage chambers are continuously monitored and data recorded.

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Case Study – Emerson Network Power

Case Study

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How Anecto developed a number of innovative solutions for the leading multinational Emerson Network Power.