SOPs for Analytical Method Development V 2.0

The purpose of this SOP is to define the steps for conducting system performance qualification (PQ) of UV-Visible spectrophotometers used in analytical method development laboratories. The PQ ensures the instrument meets accuracy, precision, wavelength calibration, and photometric linearity standards before being used for routine analysis or validation work.
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This SOP describes the process for executing system performance qualification (PQ) of Fourier Transform Infrared (FTIR) Spectrophotometers used in Analytical Method Development (AMD) laboratories. It ensures the instrument complies with regulatory standards for spectral accuracy, reproducibility, and baseline performance before it is used for sample analysis.
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This Standard Operating Procedure (SOP) defines the procedure for conducting stability-indicating method validation for pharmaceutical products. The objective is to confirm the method’s ability to quantify active ingredients and detect degradation products in the presence of excipients under various stress conditions.
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The purpose of this SOP is to define the procedures and responsibilities for the qualification, approval, labeling, storage, and usage of reference standards and working standards in analytical method development activities.
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This SOP defines the procedure for the verification of compendial analytical methods to confirm their suitability for specific applications involving the analysis of pharmaceutical raw materials, intermediates, and finished products.
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The purpose of this SOP is to establish a detailed procedure for the preparation, qualification, and approval of working standards used in analytical method development and routine testing activities within the laboratory.
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This SOP outlines the step-by-step procedure for the calibration of UV-Visible spectrophotometers to ensure accurate and reproducible results in analytical testing. Calibration ensures the instrument complies with regulatory and pharmacopoeial requirements for absorbance accuracy, wavelength accuracy, stray light, and baseline flatness.
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This SOP outlines the procedure for the qualification of High-Performance Liquid Chromatography (HPLC) systems to ensure suitability for analytical applications. The qualification confirms that the system performs reliably and complies with applicable pharmacopeial and regulatory requirements.
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The purpose of this SOP is to define the process of qualification of UV-Visible spectrophotometers used in analytical method development to confirm that the instrument performs consistently and meets regulatory requirements for analytical data generation.
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The purpose of this SOP is to establish a standardized approach for assessing inter-laboratory comparability of analytical methods. It ensures that analytical procedures yield equivalent results when executed in multiple testing facilities or external contract laboratories under defined conditions.
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