The Parenteral Drug Association has released guidance on the detection and mitigation of 2,4,6-Tribromoanisole (TBA) and 2,4,6-Trichloroanisole (TCA) taints and odors in pharmaceutical and healthcare products.
Technical Report Number 55 (TR 55) provides information on the origin of TBA and TCA odors and taints, analytical methods developed, and risk management strategies. The report highlights the uses of 2,4,6-tribromophenol (TBP) and 2,4,6-trichlorophenol (TCP); the role of fungal halophenol methylation that generates TBA and TCA haloanisole taints; and sensory and physiochemical properties of TBP, TCP, TBA, and TCA. The report also gives case examples of recalls, the root causes behind those recalls, and remedial actions taken.
From 2009 to 2011, companies in the pharmaceutical and consumer healthcare industries experienced product recalls due to the risk of product exposure to the TBA taint from tribromophenol-treated wood pallets. TR 55 offers “guidance on signal detection from adverse event and/or product quality complaints and resulting recalls, toxicology and safety, analytical method development and use, supply chain controls, risk analysis and mitigation.”
PDA members can access TR 55 for free until May 31, 2012.