Stability indicating methods are indispensable in drug development. These are adopted primarily to give substantiate the variances in drug quality with environment. A drug is sensitive to humidity, ...

Stability testing is an essential part of drug development which ensures the quality, safety and efficacy of the drug for the lifetime of the drug product. Appropriate storage conditions can only be ...

An interview with Dr. Michael Dong, about his upcoming talk at Pittcon. Why are stability-indicating methods important in pharmaceutical analysis? The stability-indicating assay is perhaps the single ...

Such testing is essential to ensure that the drug product maintains the desired efficacy and purity after transportation and storage. Various constituents of the pharmaceutical product, including the ...

Forced degradation studies can identify stability problems for drug substance and drug products. Physical, chemical, and biological stability of pharmaceutical molecules is a matter of great concern ...

The major degradation products of pralatrexate drug product formed under hydrolytic and light stress conditions were identified, synthesized and characterized using advanced spectroscopic techniques ...

Method-transfer kits help simplify analytical method transfer for global site certifications. Method transfers are required to enable critical medications to reach ...

Pharmaceuticals need to be assessed for stability to support the assigned shelf life. Therefore, when analysing stability samples obtained from these studies, analytical methods are required which are ...