Dissolution Testing

• List the operating parameters that are set on a dissolution apparatus
• Describe the final preparation checks done before adding dosage forms to dissolution media
• Describe how dissolution start time is handled for a Type 1 and Type 2 dissolution apparatus
• Explain the difference between staggering and simultaneous dosage form addition
• Describe the procedures involved in manual and automatic sampling
• Perform calculations for concentration of active in the vessel, weight of active dissolved, and percent label claim
• Compare results against USP acceptance criteria
• List examples of when retesting can be performed

Learner Benefits:

• Mastery of Dissolution Apparatus Setup: Develop a thorough understanding of how to set key parameters such as rotation speed, temperature, and dissolution time, ensuring consistent and accurate test execution.

• Confidence in Dosage Form Handling: Learn best practices for dosage form preparation and addition, including techniques to prevent floating and methods for staggered or simultaneous addition.

• Efficiency in Sampling Methods: Gain proficiency in both manual and automatic sampling, focusing on precise timing and sample volume management to maintain test validity.

• Accuracy in Critical Calculations: Strengthen your skills in calculating concentration, weight of active dissolved, and percent label claim, crucial for validating dissolution results.

• Compliance with Acceptance Criteria: Understand how to compare results against pharmacopeial standards, interpret USP acceptance stages, and determine when to conduct retesting.

• Practical Problem-Solving Skills: Equip users with the ability to identify and address potential issues, such as missing samples or improper storage, to ensure the reliability of test outcomes.

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