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For over 40 years, Butterworth Laboratories has provided independent, contract analytical services to the global pharmaceutical and related industries.
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Posted on Thursday November 16, 2023
It was 1991 and I had arrived at Berridge Environmental Laboratories in Chelmsford, hot off the train from Edinburgh where I had just completed a 5-year joint honours degree. As shared in previous Blogs, I was being mentored by Dennis, a semi-retired elderly gentleman with a shock of white hair and asbestos fingers from all […]
Read MorePosted on Thursday November 2, 2023
In our April News Bulletin, we highlighted an Article and White Paper written by our Associate Director, John Welch on the importance of the testing of excipients used in the manufacture of medicines. In both of these publications, John referenced the example of cough syrup which was manufactured by an Indonesian company between 2021 and […]
Read MorePosted on Wednesday October 18, 2023
Are we on the cusp of a helium crisis? There are many examples of scientists predicting that global helium reserves will be depleted in 20 to 35 years but we don’t believe this is credible. The Mineral Commodities Summaries 2023, produced by the US Geological Survey, part of the US Department of the Interior, reports […]
Read MorePosted on Friday June 23, 2023
Ambient temperatures in the UK are not something we usually associate as a potential risk factor. But as a weather map from the summer of 2022 illustrates, is this something we should be taking more notice of? Butterworth is used to receiving samples from clients in packaging containing temperature monitors for samples that must be […]
Read MorePosted on Wednesday June 14, 2023
It was 1991 and I had arrived at Berridge Environmental Laboratories in Chelmsford, hot off the train from Edinburgh where I had just completed a 5-year joint honours degree. As shared in previous Blogs, I was being mentored by Dennis, a semi-retired elderly gentleman with a shock of white hair and asbestos fingers from all […]
Read MorePosted on Friday June 9, 2023
At the start of May 2023, the FDA published a new Guidance for Industry document; Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol (DEG) and Ethylene Glycol (EG). My own research on this subject has been very limited, however, three things are clear. […]
Read MorePosted on Thursday February 23, 2023
The answer is NO if the chips are mounted on a printed circuit board (PCB). Manufacturers of PCBs have long understood the correlation between surface cleanliness and corrosion, electrochemical migration, dendritic growth and the resultant, current leakage, and shorting. This means that clean room technology utilised by the industry is very stringent and far exceeds […]
Read MorePosted on Thursday February 2, 2023
It was 1991 and I had arrived at Berridge Environmental Laboratories in Chelmsford, hot off the train from Edinburgh where I had just completed a 5-year joint honours degree. As shared in my last Blog, I was being mentored by Dennis, a semi-retired elderly gentleman with a shock of white hair and asbestos fingers from […]
Read MorePosted on Friday January 13, 2023
Christmas came early this year for chromatographers. After a 30 year career-long wait, on 01/12/2022, the USP General Chapter <621>Chromatography, and the JP Chromatography General Chapter were finally fully harmonised with the Ph Eur. General Chapter 2.2.46 Chromatographic Separation Techniques. The good news includes that allowable adjustments of chromatographic conditions, which were especially complex for […]
Read MorePosted on Thursday November 17, 2022
It was 1991 and I had arrived for my first day at Berridge Environmental Laboratories in Chelmsford, hot off the train from Edinburgh where I had just completed a 5 year joint honours degree. This was to be the first day of my being paid as a chromatographer. I reported to the team leader of […]
Read MorePosted on Thursday November 3, 2022
Polymeric artificial human joints are an example of a permanent contact medical devices. Since such devices are routinely sterilised using ethylene oxide (EO) after manufacture, it is a requirement of ISO 10993-7 to determine the lifetime average daily release of the resultant EO residues. This is calculated by dividing the total residue mass determined in […]
Read MorePosted on Thursday October 20, 2022
We are now seeing so many articles talking about the move to Hydrogen as the default carrier gas that it has become an industry in its own right. When budding chromatographers ask me when this will happen, my usual reply is “When the pharmacopeia say so”. The type of carrier gas is not an allowable […]
Read MorePosted on Thursday October 6, 2022
The finite nature and recent shorter-term supply uncertainties for Helium, have once again given rise to many articles with regard to its future use. Much helpful literature is available from instrument manufacturers addressing the changes to instrument hardware and chromatographic conditions required when substituting Helium with Hydrogen as carrier gas. The manufacturer’s example chromatograms using […]
Read MorePosted on Wednesday September 21, 2022
According to many sources, the storm clouds of yet another Helium shortage are gathering. This can be confirmed by the number of commentaries and graphs delivered by a simple Google search, including many which are conflicting in detail.
Read MorePosted on Friday September 2, 2022
is the preferred process to separate free amino acids, the resolved sample components can’t be detected with the required sensitivity using UV or other common universal liquid chromatography detectors.
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