The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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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To define the procedure for performing accelerated stability testing on tablet formulations, ensuring that the tablets maintain their quality, efficacy, and safety under accelerated storage conditions.
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To define the procedure for performing cleaning validation swab analysis in the quality control laboratory, ensuring that equipment and surfaces are free from residual contaminants that could affect product quality.
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To define the procedure for developing dissolution testing methods for sustained release tablets, ensuring that the release of the active pharmaceutical ingredient (API) is consistent and reproducible.
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To define the procedure for visually inspecting the uniformity of tablet coatings, ensuring that the coating process is consistent and meets product specifications for appearance and quality.
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To define the procedure for performing pH adjustment analysis in enteric-coating materials, ensuring that the pH of the coating solution is within the specified range for proper coating formation.
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