The Ultimate Resource for Pharmaceutical SOPs and Best Practices
This SOP defines the procedure for testing the acid resistance of enteric-coated capsules to ensure that they remain intact in acidic environments, as per regulatory requirements, before being released for use.
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This SOP outlines the procedure for performing identification testing of capsule fill materials to ensure that the correct substances are used in the formulation and that they meet the necessary regulatory and quality standards.
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This SOP outlines the procedure for testing residual solvents in capsules to ensure that any solvent residues from the manufacturing process are within acceptable limits to comply with safety and regulatory standards.
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This SOP outlines the procedure for sampling and testing gelatin used in the preparation of capsule shells to ensure that it meets the required quality standards for capsule manufacturing.
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This SOP outlines the procedure for conducting stability testing of capsule dosage forms to ensure that the capsules maintain their efficacy, safety, and quality under various environmental conditions throughout their shelf life.
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This SOP outlines the procedure for determining the moisture content of capsules to ensure that the capsules are within the acceptable moisture range, which is crucial for the stability and quality of the capsules.
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This SOP describes the procedure for conducting friability testing on capsules to ensure that they meet the required mechanical strength and durability criteria during handling and transportation.
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This SOP defines the procedure for performing dissolution testing of capsules to ensure that the release of active pharmaceutical ingredients (APIs) from capsules meets the required specifications under defined conditions.
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This SOP outlines the procedure for performing disintegration testing on soft gelatin capsules to ensure that they meet the required disintegration specifications and dissolve properly under controlled conditions.
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This SOP outlines the procedure for performing disintegration testing on hard gelatin capsules to ensure that the capsules meet the required disintegration specifications as per pharmacopoeial standards.
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