Establishing the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) marked a significant milestone in the global regulation of pharmaceuticals.  Originating from a 1990 meeting in Brussels, the ICH emerged as a collaborative effort between regulatory agencies and industry associations from Europe, Japan, and the United States. 

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For decades, the determination of ninhydrin-positive substances (NPS) in amino acids relied on thin-layer chromatography (TLC). However, since 2013, high-performance liquid chromatography (HPLC) has progressively replaced TLC in the European Pharmacopoeia due to its superior accuracy and efficiency.

At DAFG Laboratories, we have adopted HPLC techniques to verify the presence of 16 free amino acids in biological samples, delivering precise and reliable results for our clients.

Our latest white paper delves into this methodology and outlines how our verification process ensures compliance with pharmacopeial standards.

To read the full white paper, click HERE

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During their visit, students will participate in a presentation about the lab’s work, take a guided tour of the facilities, and engage with lab managers in a Q&A session. The visit will also offer students the opportunity to explore potential career paths within the pharmaceutical industry, providing valuable insights into future careers in science.

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At DAFG Laboratories, gas chromatography (GC) is used for accurate cellulose assays of substances like hypromellose and methylcellulose. The method, aligned with pharmacopoeial standards (USP, PhEur, JP, ChP), provides reliable testing and improved precision for clients.

While capillary columns offer sharper chromatographic results, the packed column method has historically shown better repeatability for certain analytes like methyl iodide. To mitigate risks, BLL has set stricter %RSD limits of NMT 1.0%, ensuring more reliable data and minimising the likelihood of out-of-specification (OOS) results.

To read this white paper, click HERE.

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Our journey over the past five decades has been driven by a commitment to quality, collaboration and continuous improvement.  What started with a handful of dedicated employees has flourished into a team of over 80 talented professionals, all working together to uphold our core values of integrity and excellence.

As we celebrate this historic occasion and reflect on our rich legacy, our vision remains clear: to build on our strong reputation and continue providing outstanding services to our valued customers.

On behalf of everyone at DAFG Laboratories, I would like to thank all of our customers, past and present, for supporting us and being an important part of our story. We look forward to continuing to work with you and providing our excellent  levels of services in the future.

Note: the photo above was from the original laboratories at the 41, High Street site in 1974 and below is the front page of the first brochure.

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In the pharmaceutical industry, excipients can make up as much as 90% of a drug product, meaning their quality and safety are just as crucial as that of APIs. The misconception that excipients are “inactive” can lead to overlooking potential risks, such as contamination from impurities or recycled solvents.

To read the full article published in Manufacturing Chemist, click here.

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Helium, the second most abundant element in the universe after hydrogen, is produced in stars through nuclear fusion. However, on Earth, helium is relatively scarce. It is primarily generated by the underground radioactive decay of uranium (238 U). Over time, this helium migrates through porous rock formations and eventually escapes into the atmosphere, where it dissipates into space. Due to its physical properties, helium is the only substance that escapes the atmosphere and is lost in space. Because of its inertness, if this were not the case, the concentration of helium in the atmosphere, which is stable at about 5.2 ppm, would constantly rise as the formation of geological helium continued.

To read the full article published in Manufacturing Chemist, click here.

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To read the article, click here

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Currently, we have 7 members of staff who have attended the St John’s Ambulance training to qualify as Mental Health First Aiders, where they learn to recognise warning signs of mental ill health and develop the skills and confidence to approach and support someone while keeping themselves safe. 

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