The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To provide a standardized procedure for measuring the coating thickness of sugar-coated tablets, ensuring that the coating is within the required specifications for uniformity and quality.
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To establish a procedure for pH stability testing of enteric-coated tablets, ensuring that the tablets maintain their intended performance and dissolution characteristics across a range of pH values over time.
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To establish a procedure for microbial limit testing of dispersible tablets, ensuring that the tablets meet the required microbiological standards for safe consumption.
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To define the procedure for testing related substances in extended release tablets, ensuring that the content of related substances in the tablets is within the specified limits, thereby ensuring product quality and compliance with regulatory standards.
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To outline the procedure for residual solvent testing in film-coated tablets, ensuring that the levels of residual solvents do not exceed the limits set by regulatory standards and internal specifications, ensuring product safety and compliance.
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To outline the procedure for moisture content testing in granules and tablets to ensure the proper moisture levels are maintained, preventing issues with stability, dissolution, and shelf life.
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To define the procedure for performing particle size analysis in slow-release tablets, ensuring that the particle size of the active pharmaceutical ingredient (API) and excipients is within the desired range to ensure the intended release profile.
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To define the procedure for conducting stability testing of tablet products in controlled environments, ensuring that tablets meet the required shelf-life and performance characteristics over time under specified storage conditions.
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To establish the procedure for cleaning and calibrating dissolution apparatus to ensure that the dissolution testing is accurate and reproducible, in compliance with regulatory standards and GMP.
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To establish the procedure for blend uniformity testing of granules, ensuring that the active pharmaceutical ingredient (API) and excipients are evenly distributed within the blend, achieving consistent product quality and regulatory compliance.
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