The developers of medical devices evaluate the biocompatibility of their device prior to
FDA's review and subsequent introduction to the market. Chemical characterization …

The plastics used in drug packaging systems and medical devices are composed of
homologous polymers and generally contain additives such as antioxidants, plasticizers and …

Pharmaceutical drug products (DP) can contain foreign impurities due to contact with
manufacturing, storage, distribution and administration systems. These foreign impurities …

The analysis of reference standards may be performed to enhance the qualitative and
quantitative data generated by non-specific screening methods utilized in extractables …

An extractable survey is one of several studies performed on a pharmaceutical
storage/delivery system as part of the process of demonstrating that the system is suitable for …

Leachables are substances that are leached from a medical device during its clinical use
and are important due to the patient health-related effects they may have. Thus, medical …

Rubber closures have been of great concern to regulatory authorities on account of their
potential safety risks to patients. The aim of our work is to provide part of data about the …

A drug product is chromatographically screened for organic leachables, derived from the
product's packaging system, as leachables might adversely impact the health of a patient to …

对药品杂质谱的控制是保证药品安全有效的重要措施, 也是提升国产药品质量的关键环节.
自2010 年提出实施杂质谱控制的基本策略以来, 经近十年持续的努力, 国内已经形成了一个比较 …

Background The production of hospital-compounded medicines with a longer shelf life
raises questions about drug-packaging interactions, especially desorption events involving …