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Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources. They may be added intentionally in synthesis, or may be present as contaminants, (e.g., through interactions with processing equipment or by being present in components of the drug product) and are consequently detectable in the…
Biocidal products manufactured in or imported into the EU or European Economic Area must be authorised for compliance with the requirements of the EU Biocidal Products Regulation (BPR) and any relevant national legislation before being placed on the market.
HPLC is critical to the discovery, development and eventual commercialization of pharmaceutical products. HPLC is the benchmark analytical method in the pharmaceutical industry due to its ability to score such high marks in analytical validation characteristics; including accuracy, precision, limit of detection, specificity, linearity and range, and ruggedness.
Light Scattering of macromolecules in solution has seen increasing interest over the past decades from scientists studying polymers and proteins.
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources.
Generic screening to provide fast solutions for chiral method development, whether needed for routine analytical use, trace analysis, LC/MS or preparative LC, has become increasingly important.
In this paper the suitability of reagent water for LC-MS biomedical analyses will be evaluated and the role of water quality in achieving sensitive and reliable LC-MS analyses will be discussed.
Spray-dried lactose is widely used as a filler and binder in the pharmaceutical industry, but many adults are not able to digest lactose. Therefore, it is indispensable to provide alternatives to lactose-containing drugs in order to make them suitable for lactose intolerant patients.
Having a holistic data infrastructure in place can not only save time by providing key real-time information and money through readily-accessible, enterprise-wide intelligence, it can also ensure stress-free operations.
In recent years, ultra-high performance liquid chromatography (hereinafter, UHPLC) has been widely adopted in the pharmaceutical field to improve efficiency and productivity in analytical work.
The elimination of product and process related impurities is essential to the safety and efficacy of biopharmaceuticals.
Although good auditors base conclusions on facts, emotions will play an important part in how they perceive your company, your leadership and your quality culture.
Comparative human in-vivo study of an immediate release tablet over-encapsulated by gelatin and hydroxypropyl methyl cellulose capsules –impact of dissolution rate on bioequivalence.
ISO/IEC 17025:2017, general requirements for the competence of testing and calibration laboratories, is the international reference for laboratories carrying out calibration and testing activities around the world.
How an inline vial management device is able to reject, retrieve for sampling, or reintroduce vials automatically during the loading/unloading process into pharmaceutical freeze-dryers.
