Accelerated Stability Testing of Generic Drug

Stability studies are a time-consuming and resource-intensive task. Therefore, many pharmaceutical manufacturers test their products under accelerated conditions to increase the rate of chemical and/or physical degradation. Accelerated stability studies are generally carried out by storing the product at higher temperatures and/or humidities, allowing samples to degrade at a faster rate. It has become a useful tool for the re-evaluation of drug product by elucidating the degradation process of a drug product under abnormal storage conditions. Alfa Chemistry provides accelerated stability testing services, and delivers necessary experimental data for the consistency evaluation.

Figure 1. Accelerated stability assessment characteristics. (González-González, O.; et al. 2022)

Advantages of Accelerated Stability Testing

• Increase the rate of degradation
• A more efficient and time-saving method to predict the long-term accelerated stability of drug product
• Quickly and accurately predict the final drug expiration dates
• Quantify the effect of environmental factors such as temperature and/or humidity on products
• Provide data required for long-term stability testing studies
• Evaluate the changes of process, packaging or formulation

Requirements for Accelerated Stability Testing in the Consistency Evaluation

The FDA requires that a consistency evaluation applicant should submit 6 months of accelerated stability data to prove that the stability of the developed product is consistent with that of the Reference Listed Drugs (RLDs).

① If the proposed product is stable, the samples are taken on the 6th month for the comparison with the RLD.

② If the proposed product is unstable, three pilot scale batches are required to compare with the RLD.

Figure 2. Objectives of accelerated stability testing. (González-González, O.; et al. 2022)

Our Accelerated Stability Testing Procedure

Following the requirements established by the ICH guidelines for accelerated stability studies, it takes at least 6 months of our work to obtain preliminary stability data to include in a dossier that would be submitted to the competent regulatory agencies. In the consistency evaluation, we offer file studies and executed batch records for a minimum of three batches to provide technical support for determining the packaging, storage conditions and initial validity period of drugs.

• At least 3 batches of the sample is placed at a temperature of 40°C ± 2°C and a relative humidity of 75% ± 5% for 6 months
• If accelerated data show a significant change or failure of any attribute in one or more batches, an applicant should submit intermediate data for all three batches. In addition, the submission should contain a failure analysis (i.e., discussion concerning the observed failure(s)).
• We also provide accelerated stability testing for drugs that are particularly sensitive to environmental factors such as temperature changes, oxidation, light, ionic content, and shear

What We Offer?

• A complete accelerated stability data package
• Available for the sampling and testing for a variety of dosage forms
• Provide sufficient evidence on how the quality of your product varies with time under the influence of a variety of environmental factors