At IAS, LC-MS and LC-MS-MS analysis can profile impurities of Drug products, API, and intermediates and identify unknown impurities. Also, a specified impurity contained within the sample can be isolated, purified, and identified using spectral techniques such as NMR, Mass, FTIR, etc. Our Laboratory is equipped with flash and preparative chromatography to isolate impurities. Isolated

Ion Chromatography is a method for separating ions based on their interactions with resin (stationary phase) and the eluent (mobile phase). These phases differ between an anion column, which attracts anions, and a cation column, which attracts cations. Ion Chromatography is a sensitive separation technique that allows the determination of multiple anions or cations on

List of studies that can be performed at our laboratory for polymorphism: Morphology Identification of polymorph Evaluation of polymorph for patent Quantification of polymorph Indexing and unit-cell determination Percentage crystallinity Equilibrium solubility Intrinsic dissolution profile of the polymorph Panalytical-Malvern Empyrean XRD (Reflection/Transmission configuration) Salient Features: Polymorphic interpretation and evaluation based on literature or patent data

Elemental impurities pose serious risks to patients. Modern methods provide better analytical tests to detect elemental impurities, which will help protect patients by ensuring approved products have safe levels of these impurities. Elemental impurities include catalysts and environmental contaminants in drug substances, excipients, or drug products. These impurities may occur naturally, be added intentionally, or

In collaboration with regulatory counterparts around the world, US FDA has set internationally-recognized acceptable daily intake limits for nitrosamines. Suppose drugs contain levels of nitrosamines above the acceptable daily intake limits. In that case, FDA recommends these drugs be recalled by the manufacturer as appropriate or not be released for distribution to the market. FDA

Management of leachables is important to pharmaceutical and biotechnology/biologic product manufacturers and regulatory authorities because certain leachables above specific concentrations can present patient safety concerns and/or compatibility issues for drug product formulations. Regulatory guidelines, requirements, and various best practice recommendations state that the definitive assessment of the potential impact of contact between a packaging/delivery system