SOPs for Analytical Method Development V 2.0

This SOP describes the procedure for evaluating the thermal stability of pharmaceutical substances using gas chromatography (GC). It outlines sample preparation, heating protocols, degradation profiling, and data interpretation in line with ICH stability and stress testing guidelines.
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This SOP defines the systematic approach for selecting and optimizing carrier gas type, purity, pressure, and flow rate to achieve efficient chromatographic separation, resolution, and reproducibility in gas chromatography (GC) during method development in the pharmaceutical laboratory.
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The purpose of this SOP is to define a standardized procedure for developing a UV spectrophotometric method for the quantitative assay of Active Pharmaceutical Ingredients (APIs). The SOP ensures that the method developed is precise, accurate, and robust for quality control and validation.
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This SOP outlines the procedure for determining the absorptivity value (A 1%, 1cm) of Active Pharmaceutical Ingredients (APIs) using UV spectrophotometry, ensuring method standardization, reproducibility, and regulatory compliance with USP and ICH guidelines.
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This SOP outlines the procedure for determining the absorptivity (specific absorbance) of Active Pharmaceutical Ingredients (APIs) using UV-visible spectrophotometry. Absorptivity values are critical for API identification, concentration estimation, and compliance with pharmacopoeial standards.
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This SOP defines the procedure for performing linearity studies for UV spectrophotometric methods during analytical method development. It ensures that the method provides accurate and proportional response over a defined concentration range in accordance with ICH Q2(R1).
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This SOP describes the standardized procedure for scanning UV-visible spectra and selecting the optimal wavelength (λmax) for developing accurate and robust analytical methods for pharmaceutical substances.
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This SOP outlines a systematic approach to prepare and evaluate calibration curves using UV-visible spectrophotometry for analytical method development. The curve establishes the linear relationship between analyte concentration and absorbance, essential for quantitative analysis of Active Pharmaceutical Ingredients (APIs).
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This SOP describes the standardized procedure for developing a fingerprint region spectrum using Fourier Transform Infrared (FTIR) Spectroscopy to characterize Active Pharmaceutical Ingredients (APIs) and compare them with reference standards for identity confirmation.
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This SOP defines the standard procedure for conducting ATR-FTIR (Attenuated Total Reflectance – Fourier Transform Infrared) analysis for qualitative spectral fingerprinting and identity confirmation of Active Pharmaceutical Ingredients (APIs) and excipients in the Analytical Method Development (AMD) laboratory.
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