Whitepaper: USP 643: the wrong end of the stick
To ensure that USP/EP standards are met, TOC of highly purified water can be determined by internal purification-process monitoring.
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Whitepapers & App Notes
Article: LC-UV-MS method development for antibody drug conjugates using a non-toxic ADC-mimic
Antibody-drug conjugates (ADC) represent a rapidly emerging class of biotherapeutic molecules, which harness the specificity of monoclonal antibodies (mAb) to selectively deliver highly potent cytotoxic drugs. Like all biotherapeutics they require significant analytical characterization.
Article: Inorganic elemental impurity mixes according to ICH Q3D guidelines
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…
Whitepaper: Implications of the EU Biocidal Products Regulation 528/2012 for cleanroom disinfectants
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.
Article: Fast HPLC using fused-core particle technology for rapid screening of pharmaceutical compounds
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.
Whitepaper: Light scattering for determination of molecular weight and radius of gyration
Light Scattering of macromolecules in solution has seen increasing interest over the past decades from scientists studying polymers and proteins.
Article: Elemental impurities: certified reference materials for ICH Q3D, USP<232> & <2232> and Ph.Eur. 5.20
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources.
Article: Chiral method development strategies for HPLC
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.
Application note: Ultrapure water for LC-MS biomedical analyses
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.
Scientific poster: The use of EMDEX® in a lactose-free reformulation of cetirizine tablets
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.
Whitepaper: Saving time and money in pharmaceutical operations
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.
Scientific poster: High-speed analysis of pramipexole following the draft guidance of international harmonisation of pharmacopoeias
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.
Scientific poster: Nuvia aPrime 4A: a hydrophobic anion exchange resin for refined selectivity and recovery
The elimination of product and process related impurities is essential to the safety and efficacy of biopharmaceuticals.
Whitepaper: How to write to regulatory agencies when things go wrong: your essential guidance
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.
Whitepaper: Good as gold: Capsugel®, Vcaps® Plus capsules
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.
