Procedure for Ash Content Determination

1) Purpose

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

2) Scope

This SOP applies to all pharmaceutical substances within the facility that require ash content determination as part of quality control, following pharmacopeial guidelines and internal specifications.

3) Responsibilities

Quality Control (QC) Department: Responsible for performing ash content determination 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 muffle furnace or ashing oven is calibrated according to manufacturer instructions and method validation protocols.
    4.1.2 Verify the cleanliness and condition of crucibles and other apparatus.
    4.1.3 Stabilize the furnace at the specified temperature for ashing.

4.2 Sample Preparation:
    4.2.1 Obtain representative samples of pharmaceutical substances requiring ash content determination.
    4.2.2 Label samples with batch numbers, dates, and any other relevant information.
    4.2.3 Accurately weigh samples into pre-ignited crucibles.

4.3 Ashing Procedure:
    4.3.1 Place crucibles with samples in the muffle furnace or ashing oven.
    4.3.2 Ash the samples at a specified temperature for a defined period until complete combustion.
    4.3.3 Cool the crucibles in a desiccator and weigh them after