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 agents are fully dissolved.
- 4.2.2.2 Homogenize the mixture if necessary to ensure uniformity across the entire solution.
4.3 Filtration and Filling
- 4.3.1 Filter the solution using a sterile 0.22-micron filter and fill into vials as per the BMR for lyophilization.
4.4 Documentation
Record all steps, including weighing, chelating agent addition, and filtration, in the Chelating Agent Incorporation Logbook. QA must verify all entries.
5) Abbreviations
- BMR: Batch Manufacturing Record
6) Documents
- Chelating Agent Incorporation Logbook
7) References
- Pharmacopoeial guidelines for chelating agents in pharmaceutical formulations
8) SOP Version
Version 1.0
Annexure
Chelating Agent Incorporation Logbook Template
| Date | Chelating Agent Name | Batch No. | Quantity | Operator Initials | QA Verification |
|---|---|---|---|---|---|
| DD/MM/YYYY | Chelating Agent Name | Batch Number | Quantity (grams) | Operator Name | QA Initials |