SOPs for Analytical Method Development V 2.0

To describe the procedure for the development and validation of High-Performance Thin Layer Chromatography (HPTLC) methods for qualitative and quantitative analysis of active pharmaceutical ingredients (APIs), excipients, and finished dosage forms.
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This SOP outlines a systematic approach for the development and validation of Capillary Electrophoresis (CE) methods used in the separation, identification, and quantification of charged pharmaceutical compounds, impurities, and degradation products.
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To establish a detailed and standardized procedure for the development and validation of Ion Chromatography (IC) methods used to detect and quantify ionic impurities, including anions, cations, and organic acids, in pharmaceutical substances and dosage forms.
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To define a standard procedure for developing and validating methods using Differential Scanning Calorimetry (DSC) for evaluating thermal behavior such as melting point, crystallinity, polymorphism, glass transition temperature (Tg), and excipient compatibility of pharmaceutical materials.
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To describe the procedure for the development and validation of Thermogravimetric Analysis (TGA) methods to quantitatively determine moisture content, volatile solvents, and decomposition profiles in pharmaceutical materials including APIs, excipients, and finished products.
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To establish a detailed procedure for the development and validation of X-ray Powder Diffraction (XRPD) methods used in the identification, confirmation, and characterization of polymorphic forms in pharmaceutical substances.
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This SOP outlines the procedure for developing and validating Scanning Electron Microscopy (SEM) methods used to characterize the morphology, shape, and surface characteristics of pharmaceutical particles such as APIs, excipients, and formulations.
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To establish a standard procedure for developing and validating a Total Organic Carbon (TOC) method for use in cleaning validation programs, ensuring trace-level detection of organic residues on manufacturing equipment surfaces following product changeovers or cleaning activities.
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To establish a standard procedure for the development and validation of Raman spectroscopy methods used in the identification, characterization, and quantification of pharmaceutical raw materials, intermediates, and finished products.
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This SOP defines the procedure for developing and validating Near Infrared (NIR) spectroscopy methods used for in-process testing (IPT) of pharmaceutical materials, focusing on real-time, non-destructive analysis of blend uniformity, moisture content, and identity verification.
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