SOPs for Analytical Method Development V 2.0

This SOP provides a standardized approach for developing and validating photostability testing methods to assess the light sensitivity and degradation profile of active pharmaceutical ingredients (APIs) and drug products under controlled light exposure conditions.
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This SOP outlines the process for conducting oxidative degradation studies on pharmaceutical substances and profiling the resulting degradation pathways to support stability-indicating method development and regulatory submission.
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To establish a standardized procedure for the development and validation of analytical methods for liposomal drug products, including measurement of encapsulation efficiency, particle size, drug release, and integrity, ensuring consistency and compliance with regulatory expectations.
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This SOP describes the standardized approach for developing, optimizing, and validating analytical methods for nanoformulations in the Analytical Method Development (AMD) lab. It ensures accurate measurement of particle characteristics, drug encapsulation, release profiles, and physicochemical stability of nanocarriers.
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This SOP provides a standardized procedure for conducting in-vitro release testing (IVRT) of topical drug products such as creams, ointments, and gels to assess drug diffusion through synthetic membranes, ensuring batch-to-batch consistency and formulation performance.
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To provide a standardized procedure for the development, optimization, and validation of analytical methods used to evaluate emulsions and suspensions. The focus is on characterization of particle/droplet size, assay, viscosity, physical stability, and content uniformity.
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To define the procedure for developing and validating analytical methods for pharmaceutical creams and gels, including assay, content uniformity, viscosity, pH, drug release, and physical stability to ensure product quality and regulatory compliance.
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To establish a detailed and standardized procedure for the development and validation of LC-MS/MS analytical methods for impurity profiling in pharmaceutical drug substances and products, including unknown, known, degradation, and process-related impurities.
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This SOP outlines the procedure for developing, optimizing, and validating Gas Chromatography-Mass Spectrometry (GC-MS) methods for identification and quantification of residual solvents in drug substances and drug products, in compliance with ICH Q3C and regulatory expectations.
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This SOP defines the procedure for developing and validating headspace gas chromatography (HS-GC) methods for detecting and quantifying residual solvents in pharmaceutical raw materials, intermediates, and finished products in accordance with ICH Q3C and applicable pharmacopeial standards.
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