The European Pharmacopoeia (Ph. Eur.) has significantly modernised its free amino acid monographs in recent years, moving from thin-layer chromatography (TLC) to high-performance liquid chromatography (HPLC) with post-column ninhydrin derivatisation. This advancement delivers greater sensitivity, resolution, and reproducibility, addressing the limitations of TLC. At the same time, TLC remains in the Ph. Eur. as a cost-effective identity method, reflecting a pragmatic balance between innovation and accessibility.
However, implementing dedicated amino acid analyser (AAA) systems required for HPLC can be resource-intensive. The instruments, reagents, and expertise involved represent a substantial investment many manufacturers cannot justify in-house. This is where contract testing laboratories (CTLs) provide real value, giving pharmaceutical companies access to the most advanced technologies without the operational burden.
Butterworth Laboratories is at the forefront of this space and has validated all listed amino acids in the European Pharmacopoeia monographs, providing clients with complete regulatory confidence, having committed to the dedicated AAA platform for testing ninhydrin-positive substances, fully aligned with Ph. Eur. requirements. Our systems deliver robust impurity profiling with dual-wavelength detection, automated post-column derivatisation, and high throughput capacity. Recognising increasing industry demand, we have recently expanded our capabilities by investing in an additional AAA instrument, ensuring we can support clients with both routine testing and complex regulatory submissions, as well as retaining our expertise and investment in TLC.
By outsourcing amino acid testing to Butterworth, clients benefit from precision, reproducibility, and regulatory compliance without costly in-house infrastructure. Our expertise and validated methods give manufacturers confidence that their products meet the most up-to-date pharmacopoeial standards. Read our whitepaper on ninhydrin-positive substances analysis.
As regulatory expectations evolve, Butterworth Laboratories continues to invest in technology and expertise to provide clients with the highest standard of analytical support. We enable our partners to focus on core manufacturing while we ensure compliance, accuracy, and efficiency in amino acid analysis.
