Application note: Rapid Analysis of Genotoxic Nitrosamines by HPLC-MS/MS
Genotoxic impurities (GTI’s) are intermediate, reactive products or degradants formed during drug synthesis, formulation or storage.
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Whitepapers & App Notes
Whitepaper: Impact of the Claristep® Filtration System on recovery and adsorption of various therapeutic proteins at low sample volumes
Comparison of the Sartorius Claristep Filtration System with standard sample preparation using syringe filters.
Article: Tips & tricks: sensitivity gains in LC-MS
The prerequisite of any highly sensitive analysis via HPLC-MS (high performance liquid chromatography coupled to mass spectrometry) is the use of ultrapure solvents and reagents and careful handling of all associated materials, consumables, and systems.
Whitepaper: Stability testing blister packs inspected with Sepha’s VisionScan test method
It is a requirement of both US and EU regulations that pharmaceutical packaging operations demonstrate integrity. As technology-based solutions remain somewhat of an unknown quantity, this whitepaper tests the hypothesis that Sepha’s VisionScan test method is considered non destructive.
Journal article: Validation of Milliflex quantum for bioburden testing of pharmaceutical products
Pharmaceutical drug products must fulfill specified quality criteria regarding their microbial content in order to ensure patient safety. Drugs that are delivered into the body via injection, infusion, or implantation must be sterile (i.e., devoid of living microorganisms).
Whitepaper: Supelco preparative HPLC products for pharmaceutical development and production
There is an increasing need for purified materials in the development and production of pharmaceutical products. FDA and other regulatory agencies continue to require more stringent purity requirements on active pharmaceutical ingredients (API), including most recently chiral purity.
Whitepaper: Remediation requires transparency: A process for managing quality and compliance
Standardization and alignment of the drug development and manufacturing process allow high-performing companies to globally source and efficiently produce pharmaceutical and biopharmaceutical products.
Scientific poster: Advantage of antibody based selectivity in the purification of biologics
ADVANCES in biotherapeutics are generating an increasing range of complex molecules that present unique and often complex purification challenges.
Whitepaper: Monocyte activation test (MAT)
For pharmaceutical companies, patient safety has always been the priority. That’s why pyrogen detection has become a mandatory Quality Control test for release of any parenteral drug.
Scientific poster: High-throughput proteome analysis using 50 cm micro pillar array columns (μPAC™)
The practice of bottom-up proteomics relies to a large extent on the separation performance that can be achieved with state-of-the art nano LC-MS/MS equipment.
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.
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.
