Warning of Potential Contamination with Toxic Plasticizer

Two warning notifications have been recently published almost simultaneously by the FDA and the International Pharmaceutical Excipients Council Europe (IPEC) regarding potential contamination through toxic emulsifiers in raw materials, APIs and liquid medicinal preparations. The toxic substances

diethylhexyl-phthalate (DEHP) and diisononyl-phthalate (DINP) were found in products from two Taiwanese firms.

Both chemicals are commonly used as plasticizers for polyvinyl chloride type plastics and some traces can also be found in certain food products.

The Taiwanese authorities detected a high level of DEHP in diverse beverages, which is believed to have been added as a low-cost replacement for the more expensive palm oil. As a consequence of this criminal incident, some Taiwanese products have already been recalled from the market.

The IPEC points out that the warning is limited to DEHP and DINP and, until now, only the two manufacturers in Taiwan Yu Shen Chemical Company and Pin Han Perfumery Company are concerned. It is recommended to urgently perform a risk assessment of the excipients used in drugs. The evaluation should definitely assess the origin and the purity of the excipients used (emulsifiers/ clouding agents). The IPEC Federation has published a set of  "Frequently Asked Questions" which summarize the present state of knowledge and should help to clarify the situation.

The FDA has also published a warning notification about the same incident. The Agency stresses that until now no case of intentional substitution with these toxic phthalates had been known. Because of the overlap of the global food and pharmaceutical ingredient supply chains, FDA recommends to urgently control all products from drug manufacturers as well as APIs and excipients suppliers containing vegetable oils (e.g. palm oil) on eventual substitution.

This incident is a further example of the significance of both risk assessment of APIs and excipients and transparency of the supply chain.

Please also see the IPEC Europe report about the "Taiwan Incident" as well as

the FDA warning notification.

During the "

GMPs for Pharmaceutical Excipients" conference in Barcelona, Spain, on 27/28 September 2011 you will receive first-hand information about risk assessment of pharmaceutical APIs and about ExcipactTM, the certification scheme.

Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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