Overview:
Dissolution Testing is a critical analytical procedure used to determine the rate and extent to which an active pharmaceutical ingredient (API) dissolves from a solid dosage form (e.g., tablet or capsule) into a solution. This test provides essential insights into the bioavailability, performance, and consistency of pharmaceutical products.

Test Description:
The dosage form is placed in a dissolution vessel containing simulated gastric or intestinal fluid, and agitated using a USP Dissolution Apparatus (commonly Apparatus 1 – basket, or Apparatus 2 – paddle). The concentration of the drug in the fluid is measured at specific time intervals to assess how quickly and completely it dissolves.

Purpose & Benefits:

• Evaluate drug release profile and bioequivalence
• Support formulation development and quality control
• Ensure batch-to-batch consistency
• Aid in regulatory submissions and compliance

Industries Served:

• Pharmaceutical and Biotech Companies
• Contract Research & Manufacturing Organizations (CROs/CMOs)
• Generic Drug Manufacturers
• Academic and Regulatory Institutions