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 occupied by the sample without tapping.
4.3.3 Calculate the bulk density using the formula: Bulk Density = Mass / Untapped Volume.
4.4 Tapped Density Testing:
4.4.1 After determining bulk density, tap the measuring cylinder or vessel using the specified number of taps.
4.4.2 Measure and record the volume occupied by the sample after tapping.
4.4.3 Calculate the tapped density using the formula: Tapped Density = Mass / Tapped Volume.
4.5 Calculation and Documentation:
4.5.1 Calculate and report the bulk density and tapped density values based on repeated measurements.
4.5.2 Document all powder density testing procedures, instrument settings, and results in the Powder Density Testing Report.
4.5.3 Review and approve the documentation by QC Manager before releasing results.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Powder Density Testing Report
Method Validation Protocol and Report
Instrument Calibration Records
7) Reference, if any
USP General Chapter <616> – Bulk Density and Tapped Density
Pharmacopeial standards for powder density testing in pharmaceutical substances
8) SOP Version
Version 1.0