Standard Operating Procedure for conducting a system suitability test for HPLC analysis
Purpose:
The purpose of a standard operating procedure (SOP)is System Suitability Test Procedure for HPLC Analysis
Scope:
This SOP outlines the steps for conducting a system suitability test for high performance liquid chromatography (HPLC) analysis to ensure that the chromatographic system is capable of producing reliable and accurate results.
Definitions:
- Good laboratory practices (GLP): A set of principles and guidelines that describe the conditions and practices that must be followed to ensure that laboratory work is conducted in a consistent, reliable, and reproducible manner.
- Nonclinical laboratory study: A study that is conducted to evaluate the safety or effectiveness of a regulated product, such as a drug or food additive, in animals or in vitro systems.
Responsibilities:
- Laboratory personnel are responsible for following all practices and procedures for safety in the laboratory outlined in this SOP.
- Quality Control
Procedures:
- Prepare the system suitability test (SST) standards and samples according to the relevant analytical method.
- Turn on the HPLC instrument and allow it to equilibrate according to the manufacturer’s instructions.
- Check that all instrument settings and parameters are correct and meet the requirements of the analytical method.
- Inject the SST standards and samples into the HPLC instrument and run the chromatographic analysis according to the analytical method.
- Review the chromatograms of the SST standards and samples to ensure that they meet the acceptance criteria specified in the analytical method. The acceptance criteria may include factors such as peak resolution, peak symmetry, tailing, and peak capacity.
- Calculate the results of the SST standards and samples according to the analytical method.
- Compare the calculated results to the acceptance criteria specified in the analytical method.
- If the results meet the acceptance criteria, the system is considered suitable for use. If the results do not meet the acceptance criteria, troubleshoot the problem and take corrective action as necessary.
- Document the SST results and any corrective actions taken in the laboratory notebook.
Approval: This SOP has been reviewed and approved by the QAU.
Date of last review: [insert date]
Date of next review: [insert date]
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