World supply shortage of Acetonitrile sets to cause major headaches in the pharmaceutical sector

2009-01-15
Acetonitrile refining capacity cut short by damage caused by Hurricane Ike, coupled with the global financial downturn and falling demand for cars, mean that sourcing Acetonitrile is set to become increasingly difficult.

It is the most widely used solvent in chromatographic testing (HPLC), which is used extensively by the pharmaceutical sector for QC testing of finished product prior to batch release.
Much of the world supply of this chemical, which is a form of cyanide, is derived from the manufacture of plastic components that are widely used in the automotive industry.  The by-product is refined to create Acetonitrile.

With supplies dwindling, companies that use Acetonitrile in HPLC and other processes are advised to stockpile their own supplies of virgin material, whilst also investigating the feasibility of toll laundering their waste solvents.

Companies making solid dose pharmaceuticals are likely to have the greatest success in recovering Acetonitrile from waste solvents, but those manufacturing sterile liquid injectables, for example, that tend to produce a very aqueous solvent waste may struggle.

Remsol has begun investigating the options for purchasing recovered Acetonitrile in bulk with a view to bottling this and making it available to its existing waste and environmental management client base in the pharmaceutical sector, but sourcing it is proving difficult and costly - at around £7,000 per tonne depending on purity and water content.

So, we're now exploring small-scale toll laundering options instead.  Because these are likely to be expensive or even technically infeasible if the volumes involved are too small, we've set about trying to rally the pharmaceutical sector and UK universities in an effort to gain their committment to effectively 'pool' arisings of ACN-bearing HPLC solvent waste and funnel this into the solvent recovery and chemical refining capacity that exists around the country, via Remsol.

Lee Petts, managing director at Remsol comments: "With supplies declining rapidly, it seems sensible to try and divert HPLC solvent waste containing recoverable ACN away from traditional disposal and recycling methods and into toll recovery instead.  We've contacted dozens of pharmaceutical manufacturers and CMOs in the last week, outlining our plans to set-up a pooling system for their HPLC wastes so that we can generate an overall quantity of material that will make recovery and re-supply a realistic option,"

The reality is that individual pharmaceutical companies are unlikley to generate sufficient volumes themselves to make toll laundry work, but by collaborating with Remsol in this unique scheme, it is possible that collectively they will be able to succeed and find away to make their acetonitrile go that bit further.

"This may not be the whole of the solution, but whilst pharmaceutical companies in partciular explore alternative laboratory methods such as UPLC for testing the potency and purity of their drugs, as well as seeking substitute solvents - both of which are likely to involve lengthy validation processes as a result of Change Control - a laundry service might just alleviate some of the burden and make supplies last a bit longer and so it's worth pursuing.  Already, we've received a number of positive responses from the industry about this move and hope to have the scheme operational within a couple of months." concludes Lee.

In the coming weeks, Remsol will be contacting the Association of the British Pharmaceutical Industry to seek the support of its members in getting a toll recovery operation for HPLC waste solvents established quickly.

The chances of success will be limited without the necessary critical mass of waste to process, and so businesses are urged to commit to the project at the earliest opportunity.
To find out more about this latest development and how you can get involved to safeguard your supplies of acetonitrile and carry on releasing your finished pharmaceutical products, contact us now.