SOPs for Analytical Method Development V 2.0

To define a standard procedure for the development and validation of Dynamic Light Scattering (DLS) methods used for determining the particle size distribution and polydispersity index (PDI) of nanoscale pharmaceutical formulations.
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This SOP outlines the standardized procedure for determining the specific surface area of pharmaceutical powders and porous solids using the BET (Brunauer–Emmett–Teller) method. Surface area data is critical for understanding dissolution rates, adsorption properties, and compressibility in formulation development.
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To establish a standardized procedure for conducting In-Vitro Permeation Testing (IVPT) of topical and transdermal pharmaceutical products to evaluate drug diffusion across membranes using Franz diffusion cell apparatus.
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This SOP defines a standardized method for evaluating the syringeability and injectability of parenteral formulations. The procedure aims to assess physical and functional attributes such as ease of syringe withdrawal, gliding force, and required injection pressure.
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This SOP establishes a validated analytical procedure for determining residual oxygen content in pharmaceutical container headspace using Gas Chromatography (GC) equipped with a Thermal Conductivity Detector (TCD) or Barrier Discharge Ionization Detector (BID). This test ensures the effectiveness of nitrogen purging, container closure integrity, and product stability.
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This SOP establishes a validated procedure for measuring the color uniformity of pharmaceutical formulations using objective instrumental methods such as colorimetry or UV-visible spectrophotometry. It ensures compliance with visual appearance specifications and formulation consistency.
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To define a validated method for determining the osmolality of parenteral formulations using a freezing point depression osmometer. The method ensures the safety, isotonicity, and compatibility of intravenous, intramuscular, or subcutaneous products with physiological fluids.
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To establish a standard procedure for performing forced degradation studies on active pharmaceutical ingredients (APIs) and finished products to demonstrate the specificity and stability-indicating nature of analytical methods. The studies help in identifying potential degradation pathways and degradation products.
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This SOP outlines the process for developing and validating analytical methods for photostability testing of pharmaceutical drug substances and products. It is intended to demonstrate the susceptibility of molecules to light and ensure formulation integrity during shelf life under ICH Q1B conditions.
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This SOP defines the procedure for conducting acid and base hydrolysis stress testing to evaluate the intrinsic chemical stability of active pharmaceutical ingredients (APIs) and formulations. It supports the development of stability-indicating methods under ICH Q1A(R2) guidelines.
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