USP revises monographs to tackle contamination

By Nick Taylor

- Last updated on GMT

Related tags: Ethylene glycol

The USP is revising monographs of four pharmaceutical excipients in light of hazards associated with diethylene glycol contamination and is seeking comments from interested parties.

Draft compendial methods for propylene glycol, sorbitol solution, sorbitol sorbitan solution and noncrystallising sorbitol solution have been posted online by the US Pharmacopeia (USP). A procedure for maltitol solution will be added in the near future.

These excipients have been identified as being at risk of diethylene glycol adulteration, which has led to deaths around the world, and consequently the US Food and Drug Administration (FDA) requested revisions to the monographs.

The strengthened and revised monographs should demonstrate the absence at not more than (NMT) 0.10 per cent of diethylene glycol and ethylene glycol.

To achieve this goal all four monographs have added a gas chromatography procedure. In addition, USP reference standards will be updated to include diethylene glycol and ethylene glycol.

The complete revised monographs can be found here. Informal comments are being sought until August 14. It is predicted that the monographs will come into force on February 1, 2010.

Global effort

In recent months the USP has launched several initiatives to raise quality standards in emerging markets. Since the agreement with Russia in April the USP has made similar partnerships with China, the Association of Southeast Asian Nations (ASEAN) and Vietnam.

The arrangement of China includes three separate memorandums of understanding (MOU) with regional regulatory bodies in Guangzhou, Beijing and Zhejiang.

In addition the Chinese Pharmacopoeia Commission (ChP) is jointly developing standards for active pharmaceutical ingredients (API) that have been identified by the FDA and China State Food and Drug Administration (SFDA) as being especially important.

The USP has also entered into a MOU with ASEAN to strengthen capacities and certification status of national drug quality laboratories. In a separate arrangement with ASEAN member Vietnam the USP entered into a MOU aimed at building a collaborative working relationship.

Updating written standards, mutual testing of potential reference standards, scientist exchange programmes and joint participation in planning and policy meetings are covered by the MOU.

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