The International Pharmaceutical Excipients Council is cooperating with FDA officials to provide excipient samples for counterfeit and contamination testing in a database collected by the Division of Pharmaceutical Analysis (DPA) within the US FDA’s Center for Drug Evaluation and Research (CDER).
Initial screenings will be done using four technologies to quickly identify materials that greater analysis and monitoring in the drug supply chain, reports SecuringPharma.
X-ray fluorescence will be used to detect poisonous metals in counterfeit medications Ion mobility spectrometry will be used to identify illicit drugs in dietary supplements. In addition, Raman and near-infrared spectrometry will be used to detect contaminated drug ingredients.
IPEC Americas is providing the samples, which are pharmacologically inactive bases used as carriers for the active ingredients in medication.
Often counterfeiters substitute expensive safe excipients for cheap, deadly ingredients. In the past three years, diethylene glycol was substituted in fake teething medication in Nigeria and in cough syrup in Panama. Over 100 people died.
By S. Imber