Procedure for Powder Density Testing

1) Purpose

The purpose of this SOP is to outline the procedure for determining the powder density of pharmaceutical substances using appropriate analytical techniques.

2) Scope

This SOP applies to all pharmaceutical powders within the facility that require powder density testing as part of quality control, following pharmacopeial guidelines and internal specifications.

3) Responsibilities

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

4) Procedure

4.1 Apparatus Setup:
    4.1.1 Ensure the density measuring apparatus (e.g., tapped density tester, bulk density tester) is calibrated according to manufacturer instructions and method validation protocols.
    4.1.2 Verify the cleanliness and condition of the measuring cylinder or vessel.
    4.1.3 Stabilize the apparatus at the specified temperature and environmental conditions for accurate measurements.

4.2 Sample Preparation:
    4.2.1 Obtain representative samples of pharmaceutical powders requiring density testing.
    4.2.2 Label samples with batch numbers, dates, and any other relevant information.
    4.2.3 Ensure samples are properly sieved to remove aggregates and achieve uniform particle size distribution.

4.3 Bulk Density Testing:
    4.3.1 Place a known mass of the sample into the measuring cylinder or vessel.
    4.3.2 Measure and record the volume