Standard Test Procedure (STP): How to Decide

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Table of Contents

• Introduction
• What is the STP?
• 11 Important Sections of the STP 
• Approval Section
• Safety and precaution sections
• List of chemicals and Mobile phase preparation
• Chromatographic condition
• Solution preparation
• Procedure
• Calculation 
• Applications of the STP
• Typical chromatograms
• Conclusion
• FAQs

Introduction and out come

The standard test procedure (STP) is a very important document on which laboratory analysis, method validation and technology transfer of method are done. A small mistake in standard test procedure can cause a lot of problems while doing the analysis. Now the question is, how can a universal standard test procedure be prepared? That is what I am going to explain in this blog. In this article, I will discuss standard test procedure, its different sections, advantages and applications.

What is the Standard Test Procedure (STP)?

A standard Test procedure is an Analytical document that contains a detailed analysis procedure of any test. STP is designed and prepared according to the method. For example; the STP of chromatographic method will be different from the STP of the titration method.

11 Important Sections of the Chromatographic Standard Test Procedure (STP)

The STP must have the following eleven sections:

1. Approval section
2. Safety considerations
3. List of chemicals
4. Mobile phase preparation
5. Chromatographic condition
6. System suitability evaluation and RTs and RRT and structures table
7. Solution preparation
8. Procedure
9. Calculation
10. Abbreviation
11.  Typical chromatograms

Note: Some of the pharmaceutical companies also include molecular formulae, molecular and structure of main analyte in the STP.

Approval Section

This section includes the names and signatures of the individuals who prepared the STP and those who reviewed and approved the STP. It also contains other details like the effective date, replaced date, report number etc.

Safety and precaution section

This section includes all the precautions that should be taken while performing the analysis e.g MSDS or Material safety data sheet, Laboratory coat, Safety goggles, Personal, dust or liquid face shield, Gloves

List of chemicals and Mobile phase preparation

This section includes the names of the recommended chemicals, their grade, part number, and the name of the manufacturer required for the respective method. Most of the time noise and isolation problems arise when the recommended chemicals are not used. In the absence of similar chemicals, the provision of equivalent chemicals has also been kept in this section.

Mobile phase preparation

This section contains details of mobile phase preparation procedures like buffer preparation, filtration, filter paper quality/pore size and mixing of aqueous and organic solvents.

Note: Sometimes allowable adjustment in the mobile phase is also included.

Chromatographic condition

This section contains Instrument details, column details, wavelength, injection volume,  mobile phase flow rate, column temperature, run time, diluent etc

System suitability evaluation and RTs and RRT table

This section contains system suitability acceptance criteria and retention time as well as the relative retention time of different components.

Solution preparation

This section contains the preparation of SST (system suitability test) solution, QL solution (this test will not applicable for assay), standard preparation and sample preparation (there may be minor variation as per individual method requirement).

Procedure

This section contains injection order, injection procedure, integration procedure, rejection of the peak (if applicable).

Calculation 

This section contains details calculation e.g. % area/area normalisation  and external standard method

Typical chromatograms

This section contains typical blank chromatograms, SST chromatogram, QL chromatogram, standard chromatogram and sample chromatogram

Applications of the Standard test procedure (STP)

The following are the application of the standard test procedure:

• To perform analysis in the Analytical research department
• To prepare monograph in the QC department
• To perform analytical method mini-validation and analytical validation
• To perform technology transfer in QC or one site to another site

Conclusion

Since quality depends upon the exactness of the analysis and analysis depends upon the STP and hence it must be reviewed by all technical persons before finalising the same.

Case Study: Typical STP of related substances of an API

Abbreviations:

• STP: Standard test procedure
• SST: System suitability test
• DL: Detection limit:
• QL: Quantification limit
• RT: Retention Time
• RRT: Relative retention time
• MSDS: Material safety data sheet

FAQS

What is the STP (standard test procedure) in the pharmaceutical industry?

A standard Test procedure is an Analytical document that contains a detailed analysis procedure of any test

What are the different sections of STP (standard test procedure)?

STP contains approval section, the structure of the analyte, safety precautions, chemicals and reagents used in the analysis, chromatographic conditions, sample preparation, procedure, calculation and typical chromatogram

What is the testing procedure (standard test procedure)?

A Testing procedure is an Analytical document that contains a detailed analysis procedure of any test of the pharmaceuticals

What are different applications of STP (standard test procedure)?

STP is used to perform analysis in R&D, to prepare monograph in QC and to perform technology transfer.

What are the steps of the standard test procedure?

Preparation, review, approval and distribution are the different steps of the STP

What is the standard test method?

Standard test method contains complete

What did STP stand for?

STP stand for standard test procedure