Test guards against acetonitrile adulteration

Worldwide scarcity of acetonitrile, a solvent widely used in pharmaceutical manufacturing, has led to concerns that unscrupulous individuals could adulterate supplies with other chemicals for financial gain.

The shortage in the solvent came about as a result of lower output of the chemical from China as production was shut down for the Olympics, as well as hurricane damage to a major US supplier in 2008.

As a result companies are seeking alternative solvents to minimise the impact of the shortage, as well as alternative analytical methods to ensure that supplies are of appropriate quality.

A new report from the recently set up Rx-360 industry group, which tackles issues related to supply chain security issues, indicates that prices of acetonitrile are now ten-fold higher than pre-shortage levels.

The group recently carried out a brainstorming session to try to second guess ways in which acetonitrile may be diluted or adulterated in order to fool current analytical tests. As a result of that effort, it has developed an alternative analytical method for acetonitrile which is detailed on its website and can be downloaded free of charge here (requires registration).

EDQM offers help

Meanwhile, the European Directorate on the Quality of Medicines (EDQM) recently published a reminder to companies which hold Certificates of Suitability (CEPs), pointing out they will have to submit any changes related to acetonitrile analysis for approval.

However, the EDQM’s Certification of Substances Division says it will assess any resulting revision of CEP applications as a fast-track procedure (within one month of receipt), provided no other changes are included in the request for revision.

The Directorate also says it is receiving an increasing number of requests for technical advice on a range of topics, so has decided to offer face-to-face meetings at its premises in Strasbourg, France.


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