Rx-360 warns of contamination in pharma chemical

Rx-360 reports that some pharmaceutical companies are experiencing contamination problems affecting tromethamine and related substances used in drug manufacturing that are sourced from "certain areas of China."

Tromethamine (Tris (hydroxymethyl)aminomethane), which is also known as Tris and Tris buffer has a variety of uses in pharmaceutical production, including as an intermediate, a solubiliser, a stabiliser and a buffering agent in injectable, oral, topical and ophthalmic preparations.

Rx-360's latest Flash report notes that supplies of tromethamine have been identified which are contaminated with formaldehyde/para-formaldehyde. This is a common impurity in crude Tris but should be much reduced in supplies used for pharmaceutical purposes.

The consortium notes that one of its members, Mallinckrodt Baker, is developing an ultraviolet screening method to detect compounds "that could present problems for certain biotech applications." When available the test method will be released to Rx-360 members.

Rx-360 tackles issues related to supply chain security and is trying to bring drugmakers, suppliers, distributors and brokers into alignment with a global, consistent and auditable set of quality standards.

Part of its remit is to respond to emerging threats to the supply chain and to develop safeguards against them, including new analytical tests. Last year, the group also developed a new analytical method to detect adulteration of acetonitrile, a solvent widely used in pharmaceutical manufacturing.


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