The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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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To define the procedure for testing the acid resistance of enteric-coated tablets, ensuring that the coating remains intact and protects the active pharmaceutical ingredient (API) from stomach acid, as per regulatory standards and product specifications.
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To define the procedure for preparing analytical standards for use in quality control testing, ensuring the accuracy, precision, and reliability of testing methods for raw materials and finished products.
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To define the procedure for identification testing of active ingredients in tablets, ensuring that the correct active pharmaceutical ingredient (API) is present in the tablets and that the drug is compliant with product specifications.
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To define the procedure for microbial endotoxin testing of tablets, ensuring that endotoxin levels in the tablets meet the regulatory limits for product safety and efficacy.
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To define the procedure for analyzing the impact of compression force on tablet hardness, ensuring that tablets meet the required hardness specifications for product quality and performance.
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