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June 13, 2024
Background: Contamination with diethylene glycol or ethylene glycol has been detected in an increasing number of pharmaceuticals in recent years. These substances, or more precisely, their […]
March 7, 2024
Background: On 1st March 2023, the Federal Institute for Medicinal Products and Medical Devices (BfArM) released its updated statement on testing pyrrolizidine alkaloid levels in order […]
March 1, 2024
Background: The final version of ICH Q14 “Guideline on analytical procedure development” was published at the end of December 2023. It describes science and risk-based approaches […]
January 22, 2024
Background: Melatonin is a hormone that is produced in the pineal gland of the brain and plays a key role in regulating the sleep-wake cycle. There […]
October 22, 2023
Background: Moulds of the genus Alternaria are ubiquitously distributed on plants. The Alternaria metabolite alternariol and its monomethyl ether are classified as being genotoxic (EFSA 2011). […]
October 20, 2023
Background: ICH Guideline Q3D on elemental impurities outlines a process for the evaluation of toxicity data for potential elemental impurities, the establishment of a permissible daily […]