Analytical instruments assist the pharmaceutical manufacturing process in important ways. The devices can verify the identity and purity of raw materials, determine the appropriate end point of a process such as mixing, and ensure the quality of final dosage forms. Used in process analytics, these devices could one day help to enable the real-time release of finished products. This month's highlighted machines represent new developments in analytical instrumentation. Waters's analyzer can help scientists switch between liquid-chromatography methods. Malvern's light-scattering instrument aids protein characterization. A spectrometer from Hiden enables users to determine the end point of a lyophilization process.
Analytical system enables switch to UPLC
The ACQUITY UPLC H-Class System from Waters (Milford, MA) uses a format familiar to users of high-performance liquid chromatography (HPLC) to help them switch to ultrahigh performance liquid chromatography (UPLC) methods easily. The system lets scientists transfer methods between HPLC and UPLC seamlessly, according to William Foley, the company's director of LC products.
The flow-through needle design of the system's sample manager supports sample injections from UPLC volumes (e.g., less than 2 μL) to HPLC volumes (e.g., 250 μL). The system's quaternary-solvent manager resembles that of an HPLC system, but provides UPLC performance. The ACQUITY system's active preheater (APH) reduces dispersion and bandspreading, thus enabling high-efficiency separations. The APH also helps scientists transfer methods between systems by ensuring that temperatures are equivalent.
ACQUITY UPLC H-Class system Waters www.waters.com
Instrument requires small sample volumes
Malvern's (Malvern, England) Zetasizer μV uses dynamic and static light-scattering techniques to characterize proteins. The instrument is designed to provide high sensitivity and yield rapid, accurate, and repeatable protein-size and molecular-weight data. The Zetasizer μV requires samples of only 2 μL, and a sample can be recovered fully after the measurement. Because of the small sample size required and the unit's high sensitivity, the instrument can analyze small quantities of protein. For example, the Zetasizer μV can measure 40 ng of bovine serum albumin.
Zetasizer μV instrument Malvern www.malvern.com
Spectrometer enables real-time analysis
The Transient mass spectrometer from Hiden Analytical (Warrington, England) includes pulse ion-counting detection and a heated, silica-lined, capillary-sampling inlet to provide results in less than 150 ms. The instrument enables real-time quantitative analysis and responds to gas-composition changes that are smaller than the parts-per-million (ppm) scale. The instrument offers as many as 500 measurement points per second.
Transient mass spectrometer Hiden Analytical www.hidenanalytical.com
The analyzer's heated, viscous-flow capillary and fittings with low dead volumes enable its fast response times. The unit includes a HAL 3F/PIC mass spectrometer that offers 32-bit counting, thus providing a seven-decade continuous dynamic range that enables rapid analysis at concentrations at the ppm scale. The spectrometer's data-acquisition program records and displays information quickly. The program includes a soft-ionization mode for analyzing complex mixtures and a quantitative-analysis mode. Scientists can use the spectrometer to determine the end point of the lyophilization process and analyze solvents, water vapor, and air gases.