Procedure for Loss on Drying Testing

1) Purpose

The purpose of this SOP is to outline the procedure for determining the loss on drying of pharmaceutical substances using appropriate analytical techniques.

2) Scope

This SOP applies to all pharmaceutical substances within the facility that require loss on drying testing as part of quality control, following pharmacopeial guidelines and internal specifications.

3) Responsibilities

Quality Control (QC) Department: Responsible for performing loss on drying testing and ensuring compliance with this SOP.
Analytical Laboratory: Responsible for conducting analysis using suitable techniques and interpreting results accurately.

4) Procedure

4.1 Instrument Setup:
    4.1.1 Ensure the moisture balance or drying oven is calibrated according to manufacturer instructions and method validation protocols.
    4.1.2 Verify the cleanliness and condition of the drying chamber or balance pan.
    4.1.3 Stabilize the instrument at the specified temperature and operating conditions for accurate measurements.

4.2 Sample Preparation:
    4.2.1 Obtain representative samples of pharmaceutical substances requiring loss on drying testing.
    4.2.2 Label samples with batch numbers, dates, and any other relevant information.
    4.2.3 Ensure samples are weighed accurately and placed in suitable containers for drying.

4.3 Drying Procedure:
    4.3.1 Place the sample in the moisture balance or drying oven and start the drying process.
    4.3.2 Dry the sample