The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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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To outline the procedure for testing the uniformity of multiple-layered tablets, ensuring that each layer of the tablet contains the correct amount of active pharmaceutical ingredient (API) and excipients.
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To define the procedure for validating analytical methods used to determine the quality, potency, and purity of tablets, ensuring that these methods are accurate, precise, and reproducible.
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To define the procedure for performing HPLC (High-Performance Liquid Chromatography) testing for drug content in tablets, ensuring that the active pharmaceutical ingredient (API) in tablets is within the specified limits and meets quality requirements.
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To define the procedure for content uniformity testing of immediate release tablets, ensuring that the active pharmaceutical ingredient (API) is consistently distributed within each tablet and meets the required specifications.
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To outline the procedure for testing the adhesion of the film coating to tablets, ensuring that the coating adheres properly to the tablet surface without detaching or compromising the product quality during handling and storage.
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