For over 40 years, Butterworth Laboratories has provided independent, contract analytical services to the global pharmaceutical and related industries.
In today’s fast-moving market, pharmaceutical laboratories are required to provide analytical data that is not only accurate, but also highly sensitive, reproducible and reliable. Traditional chromatographic techniques are still important, but as compounds become more complex, concentrations decrease, and regulatory demands tighten, more sophisticated detection systems are required.
Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS) combines the high separation efficiency of liquid chromatography with the capabilities of mass spectrometry, providing a second dimension of separation based on mass-to-charge ratios. This makes it a highly versatile analytical platform capable of detecting and quantifying trace levels of compounds across a wide range of applications.
Although still less widespread than GC-MS, LC-MS is becoming increasingly important in pharmacopoeias for quantifying low-level impurities. Universal detectors like Refractive Index and quasi-universal detectors like UV detect nearly all compounds, but MS provides high sensitivity and specificity, with broad applicability to target analytes in complex samples, improving signal-to-noise ratios and filtering out matrix interference. It is because of this inherent selectivity and sensitivity that pharmaceutical authorities suggest using MS detection for the determination of genotoxic N-nitrosamines.
Butterworth Laboratories offers this access to advanced LC-MS/MS capability for your analytical needs using the Agilent 6475 Triple-Quadrupole Mass Spectrometer coupled with the 1290 Infinity II HPLC system. We have an experienced scientific team that can help you with a wide range of analytical needs, covering, amongst others, nitrosamine testing, cleaning validation and clinical studies, from trace-level analysis to custom analytical method development.
Greta Litauszki
Project Manager – Butterworth Laboratories Ltd