SOPs for Analytical Method Development V 2.0

This SOP outlines the procedure for optimizing the potassium bromide (KBr) pellet technique used in FTIR spectroscopic analysis. Optimization ensures consistent pellet transparency, spectrum quality, and minimizes scattering artifacts in fingerprint and functional group regions.
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This SOP defines the procedure for performing specificity testing of pharmaceutical substances using Fourier Transform Infrared (FTIR) spectroscopy. Specificity is a critical validation parameter to ensure the method can uniquely identify the analyte in the presence of excipients, impurities, or other components.
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This SOP defines the methodology for performing comparative evaluation of FTIR spectra generated during Analytical Method Development (AMD). The objective is to determine the degree of spectral similarity between test samples, reference standards, and placebos to support identity, conformity, or specificity conclusions.
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This SOP provides a structured approach for selecting suitable dissolution media in the development of dissolution methods for oral solid dosage forms. The objective is to ensure sink conditions, relevance to gastrointestinal physiology, and method robustness.
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This SOP describes the procedure for determining sink conditions for dissolution method development. It ensures that dissolution media provides adequate capacity to solubilize the entire dose of the drug substance, thereby enabling accurate and reproducible dissolution profiling.
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This SOP outlines a standardized approach for selecting the appropriate dissolution testing apparatus (USP Apparatus I to VII) based on dosage form characteristics, method development goals, and regulatory guidelines. The objective is to ensure scientific justification, method reproducibility, and discriminatory power.
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This SOP describes the procedure for the development of drug release profiles during the analytical method development phase. It ensures scientifically justified evaluation of drug release characteristics over time for different formulations under discriminatory dissolution conditions.
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This SOP defines the step-by-step process for transferring validated dissolution test methods from the Analytical Method Development (AMD) laboratory to the Quality Control (QC) laboratory or any external testing laboratory. It ensures consistency, reproducibility, and compliance with ICH, FDA, and WHO regulatory expectations.
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This SOP provides a comprehensive procedure for the development of Liquid Chromatography–Mass Spectrometry (LC-MS) methods used for qualitative and quantitative determination of drug substances, degradation products, and impurities in pharmaceutical products.
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This SOP describes the procedure for conducting mass spectral fragmentation analysis to aid in structural elucidation, impurity identification, and degradation product profiling in pharmaceutical R&D using LC-MS/MS or GC-MS/MS systems.
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