Instrumentation analysis
Instrumentation analysis
Revin Labs maintains a large inventory of modern analytical instrumentation to remain current with all compendia requirements. We offer a broad range of testing services using advanced instrumental analyses, from measuring low levels of impurities in raw materials to determining the strength and purity of finished dosage forms.
Mass Spectrometry
Revin measures the unknowns and quantification of impurities (GTI's and Nitrosamines) in the pharmaceuticals and other related compounds by using LCMSMS and GCHSMS/GCMS. We have both advanced LC and GC mass spectrometries to test GTI's and Nitrosamine impurities in the finished products as well as intermediates. In 2018, the FDA began investigating NDMA and other nitrosamine impurities, such as NDEA, NMBA, NMPA, NIPEA and NDIPA, which are also classified as probable human carcinogens and that were detected in some blood-pressure and heart-failure medicines. Revin has developed a test method, based on LC-MSMS and GCHSMS/GCMS to detect the presence of nitrosamine and GTI traces in drug products, raw materials and active pharmaceutical ingredients (APIs) as per regulatory agencies specifications.
Liquid Chromatography
Revin offers a wide variety of HPLC capabilities. We assay both APIs and finished products with this type of testing and examine peak purity, impurities, and degradation products during stability and validation studies. Detectors we use include UV (Ultraviolet), Vis (Visible), RI (Refractive Index) and PDA (Photo Diode Array). We can deploy a nearly limitless combination of columns, mobile phases, gradients and detectors to separate and quantitate analytes.
Gas Chromatography
Revin measures the purity and residual solvents of the pharmaceuticals and other related compounds. We have both FID (Flame-Ionization Detector) and TCD (Thermal Conductivity Detector) to test nearly all required compendial GC products. Direct injection and headspace auto-injectors with temperature control enable us to quickly deliver extremely accurate results. We have several systems that accommodate packed (glass and metal), capillary and megabore columns; and we offer a limitless variety of column types, packings, and liquid phase coatings.
Elemental Analysis
Metal impurities are introduced into pharmaceutical and other products from raw materials, catalysts, equipment and the environment. We measure and validate limits for elemental impurities based on the national and internal guidelines using ICP-MS.
Particle Size Distribution by Malvern 3000
We can offer particle size both dry and wet methods.
Additional Tests
Below are a few additional tests we perform. If you do not see the procedure that meets your needs please contact us for more information. Test procedures are not limited to us, we can develop and validate procedure as per customer requirement.
