Stability Testing & Analysis

Stability analysis provides evidence on how the quality and potency of a pharmaceutical drug varies with time under the influence of different environmental conditions such as temperature, humidity and light. Stability testing is required in order to set product expiration dates, recommended storage conditions and re-testing intervals.

At EMSL Analytical Labs, our stability testing services meet ICH guidelines for long-term, accelerated and comparative stability studies. Our cGMP environmental chambers are continuously monitored for temperature and relative humidity and are equipped with back-up power generation to ensure quality control, accuracy and security.

Our pharmaceutical stability testing specialists accommodate a range of needs, including analysis for clinical trials, commercial applications, ANDA and BLA as well as stability testing for NDA and IND stages. Contact EMSL today to learn more about our stability testing services.

Stability Testing Process

Stability studies having an active pharmaceutical ingredient (API) should test batches of product for physical, chemical, microbiological, toxicological and therapeutic parameters as appropriate to the product. For products not containing an API, it is sufficient to test physical, chemical and microbiological parameters.

The stability test’s storage conditions and lengths of time should be appropriate for the storage, shipping and use of the product under all climatic zones in which it is to be stored. Storage temperature conditions for the study can range from –80°C (freezing) to 50°C (tropical climates). Relative humidity conditions can range from 50% to 75%.

EMSL’s stability testing laboratories offer a full range of stability analysis services, including:

  • Stability protocol generation
  • Stability testing
  • Stability storage
  • Generation of stability summary reports
  • Generation of conditions-specific summary reports
  • Clinical & pre-clinical stability testing
  • Release testing
  • And more!

Need API or non-API stability testing services? Turn to EMSL Analytical, a national leader in microbiology laboratory testing. Contact us today to discuss your unique stability analysis needs.

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