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Stability Testing


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The purpose of stability testing is to provide evidence that under influence of a variety of environmental factors how the quality of a drug product varies with time.It helps to establish a re-test period for the drug substance or a shelf life for the product and recommended storage conditions.

Stability Testing is categorized in three different studies.

  1. Long term /Real-time ICH (nternational Conference on Harmonisation) stability testing.

    25C 2C/ 60% RH 5% RH or 30C 2C/ 65% RH 5% RH for 12 months

  1. Intermediate

    30C 2C/ 65% RH 5% RH for 6 months

  1. Accelerated

    40C 2C/ 75% RH 5% RH for 6 months

Real-time ICH stability testing is conducted at room temperatures to reproduce actual storage conditions.

Accelerated stability testing is carried out at higher temperatures to simulate long term.

At least three primary batches of the product should be submitted for testing.

The batches should be manufactured to a minimum of pilot scale by the same

synthetic route as, and using a method of manufacture and procedure that simulates the final

process to be used for production batches.

Container Closure System

The stability studies should be conducted on the drug substance packaged in a container

closure system that is the same as or simulates the packaging proposed for storage and

distribution.

Specification

Stability studies include testing of those attributes of the products that are

susceptible to change during storage and are likely to influence quality, safety, and/or

efficacy. We test your product for physical and biological change (microbiological attributes).

Testing Frequency

For long-term studies, the frequency of testing should normally be every

3 months over the first year, every 6 months over the second year, and annually thereafter

through the proposed re-test period.

At the accelerated storage condition, a minimum of three time points, including the initial and

final time points (e.g., 0, 3, and 6 months).



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Last Updated: 12/07/10

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