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 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 ...

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 ...

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.

Sufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it. While every drug molecule is unique and brings its own ...

In the pharmaceutical industry, ensuring the stability of drug formulations is of paramount importance to guarantee their efficacy and safety. CD Formulation, a leading company in the field of drug ...

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 ...