Acetonitrile Shortages

Re-developing, Validating and Licensing Alternative Analytical Methods

With the current shortage of Acetonitrile showing no abatement, many companies are now considering re-developing and validating HPLC methods that use an alternative solvent.

If you are considering making changes to methods, either licensed or pharmacopoeia monograph procedures, we at Butterworth would be very pleased to assist you with this process. 

Outsourcing the Development and Validation process could well be cost-effective and would enable your Quality Control laboratory to concentrate on your core business, until new methods have been formally approved.

The MHRA website was recently updated and now provides information on this subject (See Link:  A recent communication to us from the MHRA (see over) has highlighted what is expected of Contract Laboratories. In order that Butterworth can ensure compliance to GMP and any marketing authorisations for the relevant finished products, this process of re-developing and validating methods must be formally documented. We would than have evidence of due diligence for any Regulatory Inspections. 

Some clients are considering validating and licencing an alternative method purely as a precautionary exercise, in case the current situation last longer and supplies more difficult than currently anticipated.

For more information on this and other services Butterworth can offer, please contact our Scientific Business Manager, John Welch, either by e-mail or telephone. 

We can also assure you that Butterworth laboratories have taken steps to secure adequate supplies of Acetonitrile for the foreseeable future.

For more information on this, or if you have any general questions or enquiries please don't hesitate to get in touch.

We are Expanding!

27th March 2017

We are delighted to announce that we have secured an additional facility in Hampton,...

Read More

Join Us At Making Pharmaceuticals 2017

16th February 2017

On 25th and 26th April 2016 Butterworth Labs will be exhibiting at Making Pharmaceuticals at the...

Read More

Contact Us

Enquiries Quotation

© Copyright Butterworth 2019

Registered in England & Wales

Company registration No. 1185121