The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Screening Polymorphs of APIs Standard Operating Procedure (SOP) for Screening Polymorphs of APIs 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for screening polymorphs of Active Pharmaceutical Ingredients (APIs) during the drug development process. Polymorphism can significantly influence the solubility, bioavailability, stability, and processing characteristics of…
SOP for Solid Dispersion Screening Methods Standard Operating Procedure (SOP) for Solid Dispersion Screening Methods 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for screening solid dispersion methods in the formulation of drug candidates. Solid dispersions are a promising strategy to enhance the solubility and bioavailability of poorly…
SOP for High-Throughput Formulation Screening Techniques Standard Operating Procedure (SOP) for High-Throughput Formulation Screening Techniques 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for utilizing high-throughput formulation screening (HTFS) techniques in pharmaceutical formulation development. HTFS techniques are designed to rapidly evaluate and optimize multiple formulation parameters simultaneously, significantly…
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SOP for Use of Design of Experiments (DoE) in Formulation Screening Standard Operating Procedure (SOP) for Use of Design of Experiments (DoE) in Formulation Screening 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for applying the Design of Experiments (DoE) methodology in formulation screening. DoE is a structured…
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SOP for Compatibility Studies Between API and Excipients Standard Operating Procedure (SOP) for Compatibility Studies Between API and Excipients 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for conducting compatibility studies between Active Pharmaceutical Ingredients (APIs) and excipients used in drug formulations. Compatibility studies are crucial in ensuring…
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SOP for Preformulation Studies for Drug Candidates Standard Operating Procedure (SOP) for Preformulation Studies for Drug Candidates 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for conducting preformulation studies of drug candidates. Preformulation studies are essential in the early stages of drug development to assess the physicochemical properties…
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SOP for Screening Excipients for Formulation Development Standard Operating Procedure (SOP) for Screening Excipients for Formulation Development 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for screening excipients for formulation development. The selection of excipients is a critical step in the formulation of pharmaceutical products, influencing the stability,…
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SOP for pH-Solubility Profiling of Drug Candidates Standard Operating Procedure (SOP) for pH-Solubility Profiling of Drug Candidates 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for conducting pH-solubility profiling of drug candidates. pH-solubility profiling is an essential step in preformulation studies, providing crucial information on the solubility of…
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SOP for Stability Testing of Screening Formulations Standard Operating Procedure (SOP) for Stability Testing of Screening Formulations 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for stability testing of screening formulations in pharmaceutical development. Stability testing is crucial for evaluating the shelf life, degradation profiles, and storage conditions…
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SOP for Solubility Testing of Drug Candidates Standard Operating Procedure (SOP) for Solubility Testing of Drug Candidates 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for solubility testing of drug candidates. Solubility is a critical physicochemical property of pharmaceutical compounds, influencing their absorption, bioavailability, and overall effectiveness. This…