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.
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
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)
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 |