Standard Operating Procedure for Incorporation of Chelating Agents in Lyophilized Products

1) Purpose

This SOP outlines the procedure for incorporating chelating agents into lyophilized products to stabilize metal-sensitive active ingredients by binding metal ions that could lead to degradation.

2) Scope

This SOP applies to formulation scientists, production operators, and QA personnel involved in the preparation of lyophilized products that require chelating agents to prevent metal ion-induced degradation.

3) Responsibilities

• Formulation Scientists: Responsible for selecting appropriate chelating agents based on the formulation requirements.
• Operators: Responsible for incorporating chelating agents into the formulation as outlined in the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying the addition of chelating agents and ensuring accurate documentation.

4) Procedure

4.1 Selection of Chelating Agents

4.1.1 Criteria for Selection

• 4.1.1.1 Chelating agents must be compatible with the formulation and should not interfere with the activity of the active ingredients. Common agents include EDTA (ethylenediaminetetraacetic acid) and citric acid.

4.2 Incorporation of Chelating Agents

4.2.1 Weighing and Dispensing

• 4.2.1.1 Weigh the chelating agents using a calibrated balance as specified in the BMR.
• 4.2.1.2 Add the chelating agents to the formulation solution while stirring to ensure uniform distribution.

4.2.2 Mixing and Homogenization

• 4.2.2.1 Stir the solution using a mechanical stirrer until the chelating