Ointments: SOP for Identifying Active Ingredient Potency in Ointments – V 2.0

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SOP for Identifying Active Ingredient Potency in Ointments – V 2.0

Procedure for Identifying Active Ingredient Potency in Ointments

Department Quality Control (QC)/Quality Assurance (QA)/Analytical Development
SOP No. SOP/Ointment/064
Supersedes V 1.0
Page No. Page X of Y
Issue Date [Insert Issue Date]
Effective Date [Insert Effective Date]
Review Date [Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define a standardized method for determining the potency of active ingredients in ointments. Potency testing ensures that the product contains the correct concentration of the active pharmaceutical ingredient (API) as per regulatory and formulation specifications.

2. Scope

This SOP applies to all personnel in the Quality Control (QC), Quality Assurance (QA), and Analytical Development departments responsible for determining the potency of active ingredients in ointments during formulation development, in-process control, and final batch release.

3. Responsibilities

  • Quality Control Analyst: Conducts potency testing and records results.
  • Quality Assurance Personnel: Reviews and approves test results.
  • Production Supervisor: Ensures that the ointment batches conform to active ingredient specifications.
  • R&D and Analytical Development Team: Evaluates formulation modifications based on potency test results.
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4. Accountability

The QC, Analytical Development, and QA Managers are accountable for ensuring that potency tests are conducted accurately and documented as per regulatory and GMP standards.

5. Procedure

5.1 Equipment and Materials

  • High-Performance Liquid Chromatography (HPLC) system
  • UV-Vis Spectrophotometer (if applicable)
  • Calibrated weighing balance
  • Ultrasonic bath
  • Standard reference material of API
  • HPLC-grade solvents (e.g., methanol, acetonitrile)
  • Mobile phase buffer (as per method validation)
  • Column (as per validated method, e.g., C18)
  • Filtered and degassed purified water

5.2 Sample Preparation

  • Weigh an appropriate quantity of ointment sample (e.g., 1 g) accurately.
  • Transfer into a 50 mL volumetric flask.
  • Add solvent (as per validated method) and sonicate for 10–15 minutes.
  • Filter the solution using a 0.45-micron filter.
  • Further dilute the sample as required.

5.3 HPLC Analysis

  • Set up the HPLC system as per validated conditions.
  • Inject blank, standard, and sample solutions.
  • Run the HPLC analysis and record retention time and peak area.
  • Compare the sample peak area with the standard.
  • Calculate potency using the formula:
  • Potency (%) = (Sample Peak Area / Standard Peak Area) × (Standard Concentration / Sample Concentration) × 100
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5.4 UV-Vis Spectrophotometer Analysis (If Applicable)

  • Prepare the sample as per method validation.
  • Measure absorbance at the specified wavelength.
  • Compare absorbance with the standard curve.
  • Calculate potency using the validated formula.

5.5 Acceptance Criteria

  • The potency of the active ingredient should be within the defined specification range (e.g., 95% – 105%).
  • Results outside the acceptable range require investigation and corrective action.

5.6 Documentation

  • Record all potency test results in the Potency Test Log.
  • Document calibration details and instrument parameters.
  • QA personnel must review and approve results before batch release.

6. Abbreviations

  • GMP – Good Manufacturing Practices
  • QA – Quality Assurance
  • QC – Quality Control
  • HPLC – High-Performance Liquid Chromatography
  • UV-Vis – Ultraviolet-Visible Spectroscopy
  • API – Active Pharmaceutical Ingredient

7. Documents

  • Potency Test Log (Annexure-1)
  • Ointment Batch Potency Report (Annexure-2)
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8. References

  • WHO GMP Guidelines for Pharmaceutical Manufacturing
  • USP <621> – Chromatography
  • ICH Q2 (R1) – Validation of Analytical Procedures
  • 21 CFR Part 211 – Current Good Manufacturing Practices

9. SOP Version

Version 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Potency Test Log

Date Batch Number Sample Weight (mg) Measured Potency (%) Result Verified By
01/02/2025 OINT-101 100 98.5% Pass QA Officer
02/02/2025 OINT-102 100 99.2% Pass QA Officer

Annexure-2: Ointment Batch Potency Report

Date Batch Number Test Method Acceptance Criteria Result Final Status Approved By
01/02/2025 OINT-101 HPLC 95% – 105% 98.5% Approved QA Head
02/02/2025 OINT-102 HPLC 95% – 105% 99.2% Approved QA Head

12. Revision History:

Revision Date Revision No. Details of Revision Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
01/02/2025 2.0 Updated SOP Format Standardization of Document QA Head