March 1, 2024

Analytical development of procedures for active pharmaceutical ingredients and medicinal products

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 […]
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January 22, 2024

Melatonin in food supplements

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 […]
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October 22, 2023

Alternaria toxins in foodstuffs

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). […]
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October 20, 2023

ICH Q3D Elemental impurities

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 […]
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