SOPs for Analytical Method Development V 2.0

This SOP describes the procedure for preparation, labeling, standardization (where applicable), documentation, and storage of reagents and volumetric solutions used in the Analytical Method Development (AMD) laboratory. It ensures accuracy, consistency, and compliance with GMP and regulatory requirements.
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This SOP defines the procedure for developing and validating pH measurement methods for Active Pharmaceutical Ingredients (APIs) in the Analytical Method Development (AMD) department. It ensures accurate, reproducible, and regulatory-compliant pH determination that supports preformulation, stability, and quality assessment activities.
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This SOP describes the process for developing and validating robust pH measurement methods for pharmaceutical formulations. The procedure ensures accurate and reproducible pH readings that reflect formulation stability, performance, and regulatory expectations.
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This SOP describes the procedure for developing, optimizing, and validating titrimetric methods for the quantification of acidity in pharmaceutical APIs and formulations. The goal is to ensure accurate, reproducible, and GMP-compliant acidity measurements aligned with pharmacopeial and regulatory requirements.
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This SOP outlines the systematic approach to developing and validating titrimetric methods for determining alkalinity in APIs, excipients, and pharmaceutical formulations. The procedure ensures accurate, repeatable, and compliant results consistent with pharmacopeial standards.
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This SOP describes the procedure for developing, optimizing, and validating methods to determine Loss on Drying (LOD) for Active Pharmaceutical Ingredients (APIs), excipients, and finished pharmaceutical products. It ensures compliance with regulatory guidelines and accurate assessment of moisture content or volatile impurities.
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This SOP outlines the standardized procedure for the development and validation of methods to determine water content using Karl Fischer (KF) titration in the Analytical Method Development (AMD) department. The method ensures accuracy, specificity, and compliance with pharmacopeial standards.
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This SOP defines the procedure for developing and validating methods to determine inorganic residues (non-volatile matter) present in pharmaceutical substances and excipients using Residue on Ignition (ROI) or Sulphated Ash techniques. The goal is to ensure accuracy, reproducibility, and regulatory compliance.
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This SOP defines the procedure for developing and validating analytical methods for the determination of Total Ash and Acid Insoluble Ash in APIs, excipients, and pharmaceutical formulations using ignition and hydrochloric acid treatment, as per pharmacopeial specifications.
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This SOP defines the procedure for developing, optimizing, and validating analytical methods for the detection and quantification of heavy metals in Active Pharmaceutical Ingredients (APIs), excipients, and finished pharmaceutical products using techniques such as ICP-MS, AAS, or colorimetric wet chemistry.
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