Standard Operating Procedure for Determination of Alcohol Content in Elixir Formulations
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/216/2025 |
| Supersedes | SOP/ELX/216/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define a validated method for the determination of ethanol (alcohol) content in elixir formulations using Gas Chromatography (GC) or specific gravity-based reference method, to ensure regulatory compliance and product quality.
2. Scope
This SOP is applicable to all finished elixir products containing alcohol as a solvent or active component, tested by the QC Laboratory of the Elixir Department.
3. Responsibilities
- QC Analyst:
- Prepare and analyze samples using the approved method and record results.
- QC Supervisor:
- Verify chromatograms or readings and review accuracy of calculations.
- QA Officer:
- Verify compliance with specification and documentation practices.
4. Accountability
The QC Head is accountable for proper execution and documentation of the alcohol determination. The QA Head is responsible for final review and approval.
5. Procedure
5.1 Method Selection
- Alcohol content may be determined by:
- Gas Chromatography
5.2 Sample Preparation for GC
- Use a clean, dry 10 mL volumetric flask.
- Weigh accurately 1 mL of elixir and dilute to volume with methanol (or as per validated method).
- Filter if necessary and inject into GC vial.
5.3 GC Operating Conditions (Example Method)
- Column: Capillary column (e.g., polyethylene glycol, 30 m x 0.32 mm)
- Carrier Gas: Nitrogen or helium at appropriate flow
- Detector: Flame Ionization Detector (FID)
- Injector Temp: 200°C
- Detector Temp: 250°C
- Oven Program: 40°C for 2 min, then increase to 150°C at 10°C/min
5.4 Standard and Calibration
- Prepare standard solutions of ethanol in methanol at concentrations ranging from 1% to 10% v/v.
- Inject each standard and plot peak area vs. concentration to create a calibration curve.
- Inject test sample and determine ethanol concentration using the calibration curve.
5.5 Calculation
Alcohol (%) = (Sample Peak Area ÷ Slope of Calibration Curve) × Dilution Factor
If using specific gravity method:
Compare measured specific gravity at 20°C against reference alcohol tables and interpolate the alcohol %.
5.6 Acceptance Criteria
- The result should fall within the approved specification range (e.g., 10.0% – 12.0% v/v or as per batch record).
- Deviation from specified range requires batch hold and investigation.
5.7 Documentation
- Record results in the Alcohol Test Logbook (Annexure-1).
- Attach chromatograms or gravimetric readings and calculations to the BMR.
- Cross-verify peak retention time with the standard.
6. Abbreviations
- GC: Gas Chromatography
- FID: Flame Ionization Detector
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- BMR: Batch Manufacturing Record
7. Documents
- Alcohol Test Logbook (Annexure-1)
- GC Calibration and Maintenance Log
- Batch Manufacturing Record (BMR)
8. References
- USP General Chapter <611> – Alcohol Determination
- 21 CFR Part 211.165 – Testing and Release for Distribution
- ICH Q2(R1) – Validation of Analytical Procedures
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Alcohol Test Logbook
| Date | Batch No. | Sample ID | Method | Alcohol % (v/v) | Specification | Tested By | Checked By |
|---|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-0425-034 | ALC-Test-034 | GC | 11.3% | 10.0% – 12.0% | Rajesh Kumar | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added GC method and specific gravity as alternate method | Method Standardization | QA Head |