SOP for Use of Antioxidants in Lyophilized Formulations

Standard Operating Procedure for Use of Antioxidants in Lyophilized Formulations

1) Purpose

This SOP outlines the process for incorporating antioxidants into lyophilized formulations to prevent oxidative degradation of the active ingredients during processing and storage.

2) Scope

This SOP applies to formulation scientists, production operators, and QA personnel involved in the preparation of lyophilized products requiring antioxidants for stabilization.

3) Responsibilities

Formulation Scientists: Responsible for selecting appropriate antioxidants based on the formulation requirements.
Operators: Responsible for incorporating antioxidants into the formulation as outlined in the Batch Manufacturing Record (BMR).
QA: Responsible for verifying the antioxidant incorporation and ensuring accurate documentation.

4) Procedure

4.1 Selection of Antioxidants

4.1.1 Criteria for Selection

4.1.1.1 Antioxidants must be non-toxic and compatible with the formulation. Commonly used antioxidants include ascorbic acid, tocopherols, and butylated hydroxytoluene (BHT).

4.2 Incorporation of Antioxidants

4.2.1 Weighing and Dispensing

4.2.1.1 Weigh the antioxidants using a calibrated balance as specified in the BMR.
4.2.1.2 Add the antioxidants to the formulation solution during preparation and stir until fully dissolved.

4.2.2 Mixing and Homogenization

4.2.2.1 Stir the solution using a mechanical stirrer to ensure the antioxidants are evenly distributed throughout the solution.
4.2.2.2 Homogenize the mixture if necessary to ensure uniformity.

4.3 Filtration and Filling

4.3.1 Filter the formulation 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, antioxidant addition, and filtration, in the Antioxidant Incorporation Logbook, verified by QA.

5) Abbreviations

BMR: Batch Manufacturing Record

6) Documents

Antioxidant Incorporation Logbook

7) References

Pharmacopoeial guidelines for the use of antioxidants in pharmaceutical formulations

8) SOP Version

Version 1.0

Annexure

Antioxidant Incorporation Logbook Template


  
    Date
    Antioxidant Name
    Batch No.
    Quantity
    Operator Initials
    QA Verification
  
  
    DD/MM/YYYY
    Antioxidant Name
    Batch Number
    Quantity (grams)
    Operator Name
    QA Initials