1. Purpose of System Suitability Test for HPLC Analysis
The purpose of this Standard Operating Procedure (SOP) for System Suitability Test for HPLC Analysis is to provide guidelines for conducting the System Suitability Test (SST) as an essential component of High-Performance Liquid Chromatography (HPLC) analysis within [Company Name]. This procedure ensures the proper functioning of the HPLC system and the reliability of analytical results.
2. Scope of System Suitability Test for HPLC Analysis
This SOP for System Suitability Test for HPLC Analysis applies to all personnel involved in HPLC analysis within [Company Name]. It covers the procedures for conducting the System Suitability Test, including preparation, acceptance criteria, calculations, and documentation.
3. Definitions involved in System Suitability Test for HPLC Analysis
3.1 System Suitability Test (SST):
A set of tests and criteria used to evaluate the performance of an HPLC system before sample analysis.
4. Safety Precautions and Personal Protective Equipment (PPE)
4.1. PPE Requirements
4.1.1 Personnel conducting the SST must wear appropriate PPE, including lab coats, safety goggles, and gloves.
4.1.2 Ensure that PPE is in good condition and properly fitted.
4.2. Chemical Safety
4.2.1 Handle all chemicals and solvents used in the SST with care, following manufacturer instructions and safety data sheets.
4.2.2 Store chemicals in designated areas away from incompatible substances.
5. Equipment and Materials
5.1. HPLC System
5.1.1 Ensure the HPLC system is in proper working condition, with all components properly installed and connected.
5.1.2 Verify that the column is correctly installed, and the mobile phase is prepared according to the analytical method.
5.2. Reference Standards
5.2.1 Prepare reference standard solutions according to the specifications outlined in the analytical method.
5.3. Mobile Phase and Solvents
5.3.1 Ensure that mobile phases and solvents are of the highest purity and prepared as per the analytical method.
6. System Suitability Test Procedure
6.1. Test Parameters
6.1.1 Review the analytical method to identify the specific parameters to be evaluated in the SST, which may include resolution, tailing factor, retention time, or other relevant parameters.
6.2. Sample Preparation
6.2.1 Inject the reference standard solution into the HPLC system according to the method.
6.2.2 Record the chromatogram data, including peak areas, retention times, and any relevant parameters.
6.3. Data Analysis
6.3.1 Calculate the required parameters as per the method and compare them against predetermined acceptance criteria.
6.3.2 Ensure that all SST parameters meet or exceed the acceptance criteria.
7. Documentation and Recordkeeping
7.1. SST Records
7.1.1 Maintain detailed records of each SST session, including the date, time, instrument conditions, chromatograms, and calculated parameters.
7.1.2 Ensure that all records are signed, dated, and readily accessible for review.
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