The Ultimate Resource for Pharmaceutical SOPs and Best Practices
This SOP defines a standardized process for conducting impurity profiling using Liquid Chromatography-Mass Spectrometry (LC-MS) for drug substances and drug products. The objective is to detect, identify, and characterize known and unknown impurities at trace levels.
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This SOP defines the procedure for identifying chromatographic peaks using accurate mass-to-charge ratio (m/z) values in LC-MS and LC-MS/MS datasets. It facilitates structural confirmation, impurity profiling, and degradant identification.
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This SOP outlines the systematic procedure for developing and optimizing proton nuclear magnetic resonance (1H NMR) methods for structural elucidation, qualitative identification, and quantitative analysis of pharmaceutical substances and impurities.
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This SOP describes the standardized procedure for the interpretation of NMR spectra obtained during analytical method development. It ensures uniform practices for structure elucidation, identity confirmation, and purity assessment of active pharmaceutical ingredients (APIs) and impurities.
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This SOP defines the criteria and procedure for selecting appropriate deuterated solvents for NMR analysis, ensuring optimal solubility, minimal spectral interference, chemical inertness, and consistent peak assignment in pharmaceutical method development.
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This SOP outlines the step-by-step methodology for using Nuclear Magnetic Resonance (NMR) spectroscopy to elucidate chemical structures, particularly for unknown impurities, degradants, and novel drug candidates in Analytical Method Development (AMD).
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This SOP defines the method development procedure for determining particle size distribution (PSD) of active pharmaceutical ingredients (APIs), excipients, and drug products using laser diffraction and other appropriate techniques in Analytical Method Development (AMD).
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This SOP defines the method optimization procedure for laser diffraction-based particle size analysis, used to determine the distribution of particle sizes in active pharmaceutical ingredients (APIs), excipients, and formulated drug products.
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This SOP defines the method for measuring zeta potential using electrophoretic light scattering (ELS) for pharmaceutical dispersions, nanoparticles, and colloidal systems in order to assess their physical stability and surface charge properties.
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This SOP defines the method for measuring zeta potential using electrophoretic light scattering (ELS) for pharmaceutical dispersions, nanoparticles, and colloidal systems in order to assess their physical stability and surface charge properties.
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