Procedure for Tablet Dissolution Testing

1) Purpose

The purpose of this SOP is to outline the procedure for testing the dissolution of tablets to ensure consistent release of the active pharmaceutical ingredient (API) over a specified time period.

2) Scope

This SOP applies to all tablet batches produced within the manufacturing facility.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting dissolution testing and ensuring compliance with this SOP.
Production Department: Responsible for providing tablet samples for testing and maintaining process parameters.

4) Procedure

4.1 Sampling:
    4.1.1 Collect a representative sample of tablets from different locations within a batch according to the sampling plan.
    4.1.2 Ensure the sample size is adequate (e.g., 12 tablets) to obtain a uniform representation.

4.2 Equipment Preparation:
    4.2.1 Set up the dissolution apparatus (e.g., USP apparatus) as per the manufacturer’s instructions.
    4.2.2 Ensure the apparatus is clean and calibrated.

4.3 Dissolution Testing Procedure:
    4.3.1 Fill each dissolution vessel with the specified dissolution medium (e.g., pH 6.8 phosphate buffer).
    4.3.2 Set the apparatus to the specified rotation speed (e.g., 50 rpm) and temperature (e.g., 37°C).
    4.3.3 Place one tablet in each vessel.
    4.3.4 Withdraw samples at specified time intervals (e.g., 15, 30, 45, and 60 minutes).
    4.3.5 Analyze the samples for API content using a suitable analytical method (e.g., UV spectrophotometry).
    4.3.6 Calculate the percentage of API released over time.

4.4 Acceptance Criteria:
    4.4.1 The tablet batch is acceptable if the dissolution profile meets the specified criteria (e.g., at least 80% of API released within 45 minutes).

4.5 Documentation:
    4.5.1 Document all results, dissolution profiles, and calculations in the Tablet Dissolution Test Record.
    4.5.2 Review and approve the documentation by QC Manager.

5) Abbreviations, if any

QC: Quality Control
API: Active Pharmaceutical Ingredient

6) Documents, if any

Tablet Dissolution Test Record
Calibration Record for Dissolution Apparatus
Sampling Plan Document

7) Reference, if any

USP <711> – Dissolution
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals

8) SOP Version

Version 1.0