The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.
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The EMA and the FDA are investigating some ranitidine medicines after they were found to contain NDMA, a probable human carcinogen.
Transforming a formulation into a successful solid dose product is a complex process that involves many considerations. Given the ever-growing demand for increased tablet quantities and the goal of reducing time to market, Rob Blanchard explains how the pressure is on manufacturers to find innovative processes to improve production efficiency.
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
Young children in Spain have developed hypertrichosis, also known as ‘werewolf syndrome’, after a reflux drug was contaminated with an alopecia treatment.
Macleods has issued a recall of 32 lots of drug products that contained trace amounts of NMBA impurities.
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.
Purification of a drug from host cell protein contaminants can be challenging, with low-level contamination often remaining after purification. Vanda Dolabela de Magalhães shares discussions on the subject from six Brazilian companies working in the biotech field.
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.
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.
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.
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.
The company has announced a recall of products which were intended to be sterile after a lack of sterility assurance.