【EXPERT Q&A】How should accelerated tests be carried out in drug stability studies?

June 2, 2025  Source: drugdu 80

Drugdu.com expert's response:

 

Accelerated testing is a crucial method for assessing the stability changes of pharmaceuticals under short-term high-temperature and high-humidity conditions. It helps predict stability trends under long-term storage conditions and provides a basis for determining the shelf life and storage conditions of drugs. Below are the detailed steps and key points for conducting accelerated testing:

I. Purpose of the Test

The primary objective of accelerated testing is to accelerate the degradation or deterioration process of drugs within a relatively short period by elevating storage temperature and humidity conditions, thereby evaluating the stability of the drugs.

II. Test Conditions

Temperature: Typically, 40℃±2℃ is selected as the temperature condition for accelerated testing. This temperature, higher than the routine storage temperature, can expedite the degradation reactions of drugs.

Humidity: The relative humidity is usually set at 75%±5%. High humidity conditions are beneficial for assessing the sensitivity of drugs to moisture.

III. Test Samples

Sample Quantity: At least three batches of samples from pilot-scale production or above should be provided to ensure the representativeness of the test results.

Packaging: Samples should be packaged in market-ready packaging or simulated packaging under specific experimental conditions to reflect the stability of drugs during actual storage and transportation.

Configuration Status: For samples intended for clinical research, accelerated testing should be conducted immediately after preparation (day 0) to assess the immediate stability of the drugs after preparation.

IV. Test Duration

Accelerated testing typically lasts for 6 months. During this period, samples should be taken and tested periodically (e.g., at 0, 1, 2, 3, and 6 months) to evaluate the stability changes of the drugs.

V. Test Indicators

Appearance: Observe changes in the appearance, color, and odor of the drugs.

Assay: Determine the content of the active ingredients in the drugs to assess the degree of degradation.

Related Substances: Detect possible degradation products or impurities in the drugs to evaluate the purity of the drugs.

Dissolution or Release Rate: For drug formulations requiring dissolution or release, measure their dissolution or release rates to assess the release performance of the drugs.

Microbial Limit: For sterile preparations or drugs requiring microbial limit control, conduct microbial limit testing.

VI. Data Analysis and Evaluation

Trend Analysis: Based on the periodically tested data, plot a trend graph showing the stability changes of the drugs over time to visually demonstrate the stability variations.

Shelf Life Prediction: Predict the shelf life of drugs under long-term storage conditions based on the results of accelerated testing, combined with mathematical models such as the Arrhenius exponential law.

Risk Assessment: Evaluate the potential impact of stability issues observed in drugs under accelerated testing conditions on the safety, efficacy, and quality controllability of the drugs.

VII. Precautions

Test Condition Control: Strictly control the temperature, humidity, and other conditions of accelerated testing to ensure the accuracy and reliability of the test results.

Sample Management: Properly store and manage test samples to avoid contamination or damage during the testing process.

Record and Reporting: Keep detailed records of the accelerated testing process and results, and prepare a test report to provide necessary stability data support for drug registration and marketing.

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