Elixir Department: SOP for Preparation of Alcohol-Based Elixirs – V 2.0

Standard Operating Procedure for Preparation of Alcohol-Based Elixirs

Department	Elixir Department
SOP No.	SOP/ELX/066/2025
Supersedes	SOP/ELX/066/2022
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 the procedure for the preparation of alcohol-based elixirs, including handling of alcohol, blending with aqueous phases, and ensuring uniformity and compliance with regulatory requirements.

2. Scope

This SOP applies to the manufacturing process of all elixir formulations containing ethanol or other pharmaceutically accepted alcohols in the Elixir Department.

3. Responsibilities

Manufacturing Operator:
- Carry out the preparation, mixing, and temperature control during alcohol addition.
- Ensure proper sealing and fire safety during handling of alcohol.
Production Supervisor:
- Verify batch documentation and ensure adherence to addition sequence and temperature control.
QA Officer:
- Monitor the process, check for homogeneity, and ensure compliance with GMP.

4. Accountability

The Production Head is accountable for the correct execution of alcohol-based elixir preparation and documentation.

5. Procedure

5.1 Pre-Preparation Checks

Ensure that the mixing tank is clean and labeled as “CLEANED.”
Check and

verify the identity and quantity of ethanol/alcohol with the dispensing log and CoA.

Ensure exhaust ventilation, flame-proof electrical fittings, and availability of fire extinguishers.

5.2 Preparation of Aqueous Phase

In a clean mixing vessel, prepare the aqueous phase by dissolving water-soluble components such as preservatives, sweeteners, colorants, and API (if applicable).
Mix until all solids are dissolved completely.

5.3 Alcohol Addition Procedure

Ensure the temperature of the aqueous phase is below 30°C before alcohol addition.
Slowly add ethanol/alcohol under continuous stirring to avoid localized concentration and vaporization.
Use a closed addition funnel or pump to avoid vapor release.
Continue agitation for at least 30 minutes to ensure uniform blending.

5.4 Volume Make-up

Adjust the final volume with purified water to the batch size as per BMR.
Stir for an additional 10–15 minutes.

5.5 In-process Checks

Take samples for pH, appearance, and alcohol content (as per STP).
Document observations and results in the BMR and Alcohol Elixir Log (Annexure-1).

5.6 Safety Precautions

Always handle alcohol away from sources of ignition or heat.
Use flame-proof lighting and ensure operators wear PPE, including gloves and eye protection.
Store unused alcohol in flammable material storage cabinets with proper labeling.

6. Abbreviations

SOP: Standard Operating Procedure
BMR: Batch Manufacturing Record
QA: Quality Assurance
CoA: Certificate of Analysis
PPE: Personal Protective Equipment

7. Documents

Alcohol Elixir Log (Annexure-1)
Fire Safety Checklist (Annexure-2)
Material Usage Log for Ethanol (Annexure-3)

8. References

21 CFR Part 210 & 211 – GMP for Finished Pharmaceuticals
WHO TRS 961 Annex 3 – GMP for Liquid Dosage Forms
NF/USP Monographs on Ethanol

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 Elixir Log

Date	Batch No.	Alcohol Quantity (mL)	Added By	Mixing Time (min)	Verified By
11/04/2025	ELX-1011	5000	Rajesh Kumar	30	Sunita Reddy

Annexure-2: Fire Safety Checklist

Area	Fire Extinguisher Present	Ventilation On	Flammable Signs Visible	Checked By
Mixing Room	Yes	Yes	Yes	Manju Sharma

Annexure-3: Material Usage Log for Ethanol

Date	Material Name	Batch No.	Quantity Issued	Used In Batch	Balance
11/04/2025	Ethanol IP	ETH-0325	6000 mL	ELX-1011	1000 mL

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	Inclusion of safety protocols and updated annexures	Process Standardization	QA Head