Stability studies are a cornerstone of pharmaceutical quality. They ensure that a pharmaceutical product will maintain its efficacy and safety for its established shelf life to protect patient safety.

The purpose of the stability testing is to investigate how the raw materials or pharmaceutical preparations will change over time under the influence of temperature, humidity, and light, so as to ...

Stability testing is essential in the pharmaceutical and biopharmaceutical industries. These tests are performed to evaluate the stability of drug products under various environmental conditions. Once ...

The introduction of biologicals into our drug armamentarium is complicating stability testing. For these complex molecules neither physicochemical data nor bioassays alone provide the complete picture ...

Qalitex highlights shelf-life validation as key in regulatory submissions as agencies accelerate reviews of health-focused product categories. Stability testing remains essential in regulatory ...

Developers might invest in small-scale equipment to produce packaging for stability studies in-house, or they might outsource production. Manufacturers should consider the benefits and risks to both ...

In recent decades, shelf-life prediction is increasingly recognized as an important and necessary part of any new product development. Fully aware of this, CD Formulation, a New York-based CRO company ...

Company Invests $3 million in Equipment and Talent in its Centralized Stability Testing Lab Patheon , a leading global provider of high-quality drug development and delivery solutions to the ...

Table 1. Factors to consider in real-time stability study (click to enlarge). Figure 1. Effect of material change on stability profile (click to enlarge). Figure 2. Correleation of stability failure ...

Qalitex Labs releases industry advisory urging supplement brands to adopt proactive stability testing as global regulations and marketplace standards tighten. Stability testing is no longer optional.