Stress Testing of Generic Drug

The stress test is one of the important components of the stability study, which is the basis of the accelerated test and long-term test. Based on risk assessment and understanding of imitation varieties, Alfa Chemistry provides a comparative study of the generic drug and the Reference Listed Drugs (RLDs) by performing stress testing.

The role of stress testing in the consistency evaluation

• Re-evaluate the composition of formulation
• Assess the feasibility of analytical methods in quality research
• Select suitable pharmaceutical packaging materials and determine the optimal storage conditions

Figure 1. Testing of storage conditions for drug products. (Aashigari, S.; et al. 2019)

Our Capabilities

• Analyze the stability of the product

Analyze the affection of light, temperature, and humidity on the stability of APIs.

• Provide data support for the prescription process screening

Investigate whether there is an interaction between the active ingredients of the prescription and the excipients, and whether there is an interaction between different excipients.

Determine the dosage form of the drug product, the composition of the preparation and the parameters of the production process through the research on the stability of raw materials.

• Determine the packaging materials and storage conditions

Determine the packaging materials and storage conditions based on the stability of the preparation with the full understanding of how light, temperature, water, humidity and oxygen affect your drug product.

• Determine the possible degradation pathways and degradation products of the product

In the stress test, drug degrades under severe conditions. We study the possible degradation products of the drug, and identify the degradation pathway of the drug through the qualitative or quantitative analysis of the degradation products.

Stress Testing Services

Alfa Chemistry provides comprehensive temperature, humidity, and light testings to assess the stability of generic drugs by evaluating the differences in properties, content, and related substances between the generic drugs and the RLDs.

• Temperature testing

In the temperature testing, the RLD and generic drugs are placed at 60°C for 10 days, and samples are taken on the 5th and 10th day for the comparative analysis of related substances.

• Humidity testing

In the humidity testing, the RLD and generic drugs are placed at RH 90% ± 5% levels for 10 days, and samples are taken on the 5th and 10th day for the comparative analysis of related substances.

• Light testing

In the light testing, the RLD and generic drugs are placed at a suitable light container and exposed to light under the condition of 4500 Lx ± 500 Lx of illumination for 10 days for the comparative analysis of related substances.

In addition, according to the characteristics of generic drugs, we provide additional testings, such as investigating the effects of pH, oxygen, low temperature, freeze-thaw and other factors on the drug stability.

Our Advantages

• Ensure the safety and effectiveness of your proposed generic products in clinical trials
• Comprehensive evaluation index and system
• Adequate evaluation of product stability