News & Events

Butterworths present at the Pharmacopoeial User Forum

Monday 10th August 2009

Frank Judge and Andrew Johnson successfully gave a presentation entitled “Practical experience with the new requirements for control of residual solvents”.

Drawing from their considerable GC expertise they highlighted allowable enhancements that can be utilised in analysing according to USP <467>.

These suggested...

USP<231> Heavy Metals Testing Changes

Friday 3rd July 2009

Determination of heavy metals in drug articles

The current USP method for heavy metals Pb, Hg, Bi, As, Sb, Sn, Cd, Ag, Cu and Mo (USP) has its limitations as it is not specific or sensitive enough also it does not provide the adequate recovery of the elements being tested.

Because of these limitations the USP have proposed to replace the USP...

Acetonitrile Shortages

Monday 16th February 2009

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...

Successsful UKAS and MHRA Audits

Friday 7th November 2008

We are pleased to say that following an inspection by Lesley Graham and Andrew Gray of the MHRA, the company retain their GLP and GMP Compliance status. We were pleased to receive the new GMP Certificate for Contract Laboraotries.

The annual UKAS Surveilance visit went eaqually well and we await confirmation that our new ICP based method...

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