Bayer has solution for solvent shortage in pharma
pharmafile | August 4, 2009 | News story | Manufacturing and Production | Bayer
German chemical company Bayer says it could have a solution to help ease the current shortage of acetonitrile, a solvent widely used in pharmaceutical manufacturing.
Bayer's Technology Services unit says it has developed a ton-scale process that allows the feedstock for acetonitrile to be purified to a quality suitable for use in pharmaceutical production.
The shortages of acetonitrile came to a head in 2008 and were prompted by two major factors – decreased output of the chemical from China and hurricane damage to a factory in Texas that was a major world supplier.
But rather than getting better as we head into the latter half of 2009, the situation is actually getting worse, with demand still tight and prices increasing.
A lot of acetonitrile comes as a by-product of production of the plastics acrylonitrile and polyacrylonitrile, which go into automotive components, machinery housings and other heavy goods. With manufacturing of these items in the doldrums as a result of the global recession, production of the chemicals used to make acetonitrile are also down.
Bayer's approach does not tackle the overarching shortage in acetonitrile feedstock, but does make more of the available supplies suitable for use in pharmaceuticals. Drug manufacturers can now buy lower-grade acetonitrile and get it processed to a pharmaceutical grade.
Using the approach, technical quality acetonitrile – known as isocratic grade – can be purified to 'gradient grade' suitable for use in high-performance liquid chromatography (HPLC) or even to pharmaceutical quality, known as 'ultra gradient grade'.
The conversion price ranges from 10 to 17 euros per litre, depending on the quality of the feedstock provided, according to Bayer.
"Upon request we can deliver the pharmaceutical quality ACN to our customers in electropolished 1m3 containers," says Dr Michael Traving, head of Bayer's pilot plant facility in Leverkusen, Germany, where the technique was developed. The plant has a production capacity of 4m3 per week.
The shortage in acetonitrile has led to concern that unscrupulous individuals might be tempted to adulterate supplies with other chemicals for financial gain.
That has prompted industry to look for alternative solvents to acetonitrile, although the implications of process changes can be costly – both in terms of time and money – as they generally require notification to the regulatory authorities.
The industry-backed supply chain security group Rx-360 recently developed an alternative analytical method for acetonitrile to detect dilution or adulteration of the solvent.
Related Content
Bayer and Aignostics to collaborate for AI oncology research
Bayer and Aignostics have announced that they have entered into a strategic collaboration for several …
Bayer’s cardiovascular drug shows impressive Phase III results
Bayer’s finerenone drug has been shown to significantly reduce cardiovascular death or other cardiovascular events …
Bayer’s venous thromboembolism drug Xarelto gets UK approval for children
Bayer has received UK approval for the use of its oral Factor Xa inhibitor Xarelto …
