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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 […]
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 […]
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). […]
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 […]
August 22, 2023

Vitamin analysis for medicinal products, food and cosmetics

Background:  The PhytoLab Newsletter dated 25 April 2023 provided an overview of the services that we offer in the field of food supplements. Vitamins are outstandingly […]
August 1, 2023

Stability tests for Phytopharmaceuticals

Do you require stability studies? The PhytoLab Newsletter dated 25 April 2023 provided an overview of the services that we offer in the field of food […]