June 13, 2024

Testing active ingredients and excipients for the presence of glycols

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 […]
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March 7, 2024

Risk assessment and analysis of pyrrolizidine alkaloids

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 […]
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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 […]
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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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