SOP Guide for Pharma

Elixir Department: SOP for Conductivity Testing – V 2.0

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Elixir Department: SOP for Conductivity Testing – V 2.0

Standard Operating Procedure for Conductivity Testing in Elixir Formulations

Department Elixir Department
SOP No. SOP/ELX/232/2025
Supersedes SOP/ELX/232/2022
Page No. Page 1 of 7
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define a standardized procedure for measuring the electrical conductivity of elixir formulations, which is indicative of ionic strength, formulation consistency, and water quality used during manufacturing.

2. Scope

This SOP applies to the Quality Control Department for routine and stability testing of elixirs, and for verification of purified water and solution conductivity during formulation and packaging operations.

3. Responsibilities

  • QC Analyst:
    • Calibrate the conductivity meter, perform the test, and document the results.
  • QC Supervisor:
    • Review test results, ensure compliance with product specification, and check instrument calibration records.
  • QA Officer:
    • Ensure regulatory compliance and verification of test documentation for batch release.
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4. Accountability

The QC Head is accountable for ensuring accuracy and consistency in conductivity testing. The QA Head is responsible for verifying compliance with GMP and pharmacopeial standards.

5. Procedure

5.1 Equipment and Materials

  • Conductivity
meter with temperature compensation
  • Conductivity cell (with known cell constant)
  • Conductivity standard solution (e.g., 84 µS/cm, 1413 µS/cm)
  • Sample container (clean, dry, and conductivity-tested)
  • Purified water (for rinsing and blanks)

    • 5.2 Calibration

    1. Calibrate the conductivity meter using standard solutions traceable to NIST.
    2. Rinse the electrode with purified water between different standards.
    3. Document the calibration data in the instrument calibration logbook.

    5.3 Sample Preparation

    1. Allow the elixir sample to equilibrate to room temperature (25 ± 2°C).
    2. Transfer sufficient quantity (minimum 50 mL) into the rinsed test beaker.
    3. Ensure there are no bubbles in the sample before testing.

    5.4 Conductivity Measurement

    1. Immerse the conductivity probe in the sample.
    2. Allow reading to stabilize and record the conductivity in µS/cm.
    3. If temperature compensation is manual, adjust reading based on the temperature correction chart.
    4. Perform the test in duplicate and report the average value.

    5.5 Acceptance Criteria

    1. Conductivity should be within specified limits (e.g., 200–800 µS/cm depending on formulation).
    2. For purified water used in elixirs: NMT 1.3 µS/cm at 25°C (as per USP).
    3. Any value outside limits should be investigated and documented as per deviation management SOP.

    5.6 Documentation

    1. Record the sample identification, conductivity, temperature, and result in the Conductivity Logbook (Annexure-1).
    2. Attach instrument printouts where applicable.
    3. Ensure date, batch number, and analyst signatures are captured accurately.

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • USP: United States Pharmacopeia
    • µS/cm: Microsiemens per centimeter
    • QC: Quality Control
    • QA: Quality Assurance

    7. Documents

    1. Conductivity Logbook (Annexure-1)
    2. Instrument Calibration Log
    3. Batch Manufacturing Record (BMR)

    8. References

    • USP Chapter <645> – Water Conductivity
    • 21 CFR Part 211.160 – Laboratory Controls
    • ICH Q6A – Specifications: Test Procedures and Acceptance Criteria

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Conductivity Logbook

    Date Batch No. Conductivity (µS/cm) Temperature (°C) Specification Pass/Fail Tested By Verified By
    11/04/2025 ELX-0425-049 525 25.1 200–800 Pass Rajesh Kumar Sunita Reddy

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    01/01/2024 1.0 Initial SOP Release New SOP Creation QA Head
    11/04/2025 2.0 Updated method validation and water specification reference Regulatory Alignment QA Head
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