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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.
To ensure that USP/EP standards are met, TOC of highly purified water can be determined by internal purification-process monitoring.
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…
The process of manufacturing a biotherapeutic drug entails numerous quality control measures to ensure safety and efficacy. The articles in this in-depth focus discuss higher order structure analysis and host cell protein contamination issues.
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources.
The elimination of product and process related impurities is essential to the safety and efficacy of biopharmaceuticals.
The company has announced a recall of products which were intended to be sterile after a lack of sterility assurance.
A drug alert has been issued for two batches of paracetamol tablets found to have discolourations due to fungi.
Those who work in QC know that the job is more than a box to be checked, and that it can’t be done effectively without confidence in the reported results. Tight timelines, regulatory demands, and stringent data integrity standards can make it hard to focus on what’s really at stake…
A brief overview of how SWAN Analytical Instruments helps to ensure water quality with analysers to measure trace ozone and total organic carbon (TOC).
This application note discusses the desired future state for measuring conductivity of compendia water samples and how the Sievers M9 TOC Analyzer with Conductivity enables users to reach this state.
The MHRA has recalled three batches of Losartan tablets due to contamination with the nitrosamine N-nitroso-N-methylamino butyric acid...
FDA is 'deeply concerned' about a third type of nitrosamine impurity detected in angiotensin II receptor blocker (ARB) medicines...
The introduction of ICH Q3D (Guideline for Elemental Impurities)1 was an additional safety-based guidance for toxic impurities that complemented the existing ICH Q3C(R5) (Impurities: Guideline for residual solvents)2 and ICH M7(R1) (Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk);3 as well as the…
