SOP Guide for Pharma

Tablets: SOP for pH Adjustment Analysis in Enteric-Coating Materials – V 2.0

Auditor

Tablets: SOP for pH Adjustment Analysis in Enteric-Coating Materials – V 2.0

Standard Operating Procedure for pH Adjustment Analysis in Enteric-Coating Materials

Department Quality Control
SOP No. SOP/TAB/104/2025
Supersedes SOP/TAB/104/2022
Page No. Page 1 of 6
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To define the procedure for performing pH adjustment analysis in enteric-coating materials, ensuring that the pH of the coating solution is within the specified range for proper coating formation.

2. Scope

This SOP applies to the pH adjustment analysis of enteric-coating materials used in tablet coating processes. It ensures that the pH level of the coating solution meets the requirements for effective enteric coating.

3. Responsibilities

See also  Tablets: SOP for Optimizing Coating Suspension Viscosity - V 2.0

4. Accountability

The QC Manager is accountable for ensuring that the pH adjustment analysis is carried out correctly and that the pH values fall within the specified range. The QA Manager is responsible for approving the results and ensuring compliance with regulatory standards.

5. Procedure

5.1 Preparation of Coating Solution

  1. Prepare the enteric-coating solution according to the formulation and the coating process specifications.
  2. Ensure all required excipients and materials are available and properly mixed to prepare the coating solution.
  3. Before adjusting the pH, check the initial pH of the solution using a calibrated pH meter.

5.2 pH Adjustment

  1. If the pH is outside the desired range, adjust the pH using appropriate acid or alkali solutions (e.g., citric acid, sodium hydroxide) to bring the solution into the specified pH range for enteric coating (typically pH 4.5–5.5, but as per formulation requirements).
  2. Stir the solution continuously to ensure uniform distribution of the pH-adjusting agents.
  3. After each addition, measure the pH again using the calibrated pH meter until the target pH is achieved.
See also  Tablets: SOP for Applying Protective Seal Coating for Sugar-Coated Tablets - V 2.0

5.3 pH Verification

  1. Once the target pH is reached, verify the pH level with multiple readings from different areas of the coating solution.
  2. Record the final pH value in the batch record (Annexure-1).
  3. If the pH remains stable and within the acceptable range, proceed with the coating process. If not, re-evaluate the solution and repeat the pH adjustment process.

5.4 Documentation and Record-Keeping

  1. Document all pH adjustments and final pH values in the batch record (Annexure-1), including the reagents used and the amounts added during pH adjustment.
  2. Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.

5.5 Post-Adjustment Actions

  1. Once the pH is adjusted and documented, proceed with the coating process or store the solution as per the process requirements.
  2. Dispose of any pH adjustment reagents according to the company’s waste disposal procedures.

6. Abbreviations

See also  Tablets: SOP for Granule Bulk Density Determination - V 2.0

7. Documents

  1. Batch Record (Annexure-1)
  2. Deviation Report (Annexure-2)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number Coating Solution pH Reagents Used Amount Added Final pH Remarks
Batch 001 4.2 Citric acid 50 mL 4.8 Pass

Annexure-2: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
15/12/2025 Batch 001 pH adjustment exceeded limit Re-adjusted pH to 4.8 John Doe

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated pH adjustment procedure Refined reagent usage for pH control QA Head
Exit mobile version