Stability Studies of Generic Drug

When applying for the listing of generic drugs and the consistency evaluation of the quality and efficacy of generic drugs, under the premise that the production scale of the registered batches meets the requirements, the filing information needs to include at least three registered batch samples of six-month long-term stability test data. Therefore, stability studies play a crucial role in the pharmaceutical industry, especially in the development and evaluation of generic drugs. These studies assess the stability and shelf-life of generic drugs under various conditions, ensuring their quality, efficacy, and safety throughout their intended storage period. Focusing on drug quality research and management for many years, Alfa Chemistry provides you with reliable generic stability evaluation services in accordance with FDA guidelines.

Figure 1. The physical stability of drugs linked to quality-by-design (QbD) and in-process technology (PAT) perspectives. (Aucamp M, et al. 2019)

Alfa Chemistry's Services

Alfa Chemistry is committed to providing professional and comprehensive stability study services for generic drugs. Our state-of-the-art facilities, experienced team of scientists, and adherence to regulatory guidelines enable us to provide reliable and scientifically sound results. Our generic drugs stability evaluation services include but are not limited to:

Packaging Compatibility Testing of Generic Drug

Interactions between active ingredients and packaging materials during packaging, transportation, and manufacturing can affect the stability of a drug. Our compatibility check evaluates the impact of packaging materials on the drug product and ensures that the selected materials are suitable for maintaining drug quality and safety.

Our packaging compatibility testing platform is available for the analysis of:

• Compatibility of injections and plastic packaging materials
• Compatibility of injections and pharmaceutical glass containers
• Elastomer seal compatibility

Stress Testing of Generic Drug

Stress testing is essential for generic drug stability studies. We offer comprehensive temperature, humidity, and light testing to assess generic drug stability by evaluating differences in properties, content, and related substances between generic drugs and RLDs.

Our generic drugs stress testing services are supported in conformance evaluations with:

• Reassessment of formulation composition
• Assessing the feasibility of analytical methods in quality studies
• Selection of suitable pharmaceutical packaging materials and determination of optimal storage conditions

Accelerated Stability Testing of Generic Drug

Accelerated stability testing speeds up the evaluation process by subjecting the drug product to elevated pressure conditions to simulate real-time degradation at a faster rate. The FDA requires consistency evaluation applicants to submit six months of accelerated stability data to demonstrate that the stability of the developed product is consistent with that of the reference listed drug (RLD). We offer accelerated stability testing services and provide the necessary experimental data for consistency evaluation.

What we offer:

• Complete accelerated stability data package
• Available for sampling and testing of multiple dosage forms
• Provides sufficient evidence of how your product quality changes over time under the influence of various environmental factors

Long-term Stability Testing of Generic Drug

The FDA requires that when applying for generic drug conformity evaluation, application materials must include 6 months of long-term stability data. We offer long-term stability testing to ensure your generic product quality and regulatory compliance.

Our generic drug long-term testing services are designed to:

• Accurately reflect the stability characteristics of the product
• Be used to determine product storage conditions
• Establish predictive tools for product expiration dates

Determination of Expiration Date for Generic Drug

We utilize all available stability information, including results from accelerated and long-term testing, to determine product expiration dates. Our extrapolation methodology takes into account the RLD and multiple batches to accurately predict a drug's shelf life and meet FDA requirements for conformity assessment.

Our standard workflow includes:

• Analyzing results from accelerated and long-term stability testing
• Comparative analysis of reference formulation and generic quality study results
• Statistical analysis of data
• Determination of generic expiration dates