ICH stability chambers with continuous monitoring for long-term, intermediate, and accelerated studies supporting FDA ...

ISO 17025-accredited California lab offers HPLC, LC-MS/MS, ICP-MS, and ICH stability studies with 48-hour turnaround for FDA submissions.

Oxidation is a major degradation pathway for active pharmaceutical ingredients (APIs), particularly in solid dosage forms. It can reduce efficacy, generate toxic by-products, and shorten shelf ...

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 ...

GMP release and stability testing are indispensable elements of the pharmaceutical sector’s quality assurance strategy. These testing protocols not only ensure that pharmaceutical products are safe ...

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 ...