Learn what an STP (standard test procedure) is, how to write it, key sections, safety considerations, calculation methods, typical chromatograms, applications, and a case study for accurate lab analysis and compliance.
Introduction and Outcome
The STP (Standard Test Procedure) is a critical document in pharmaceutical laboratories that guides analytical testing, method validation, and technology transfer. Even a small error in an STP can lead to inaccurate results or compliance issues. A well-prepared STP ensures consistency, reproducibility, and reliability of analytical methods across laboratories and sites.
In this article, you will learn about STP in pharmaceuticals, its definition, key sections, applications, advantages, and a case study, along with answers to frequently asked questions.
A Standard Test Procedure (STP) is a detailed analytical document that describes step-by-step procedures for performing a specific test. It ensures that analytical methods are executed consistently and accurately.
For example:
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A comprehensive STP typically includes the following sections:
Note: Some companies also include molecular formulae and chemical structures of analytes.
STPs are used to:
| Section | Details |
|---|---|
| STP Name & Number | Name, number, edition, source, and status |
| Approval | Name, signature, and date of preparer & approver |
| Safety Details | MSDS review, work in fume hood, PPE requirements |
| Chemicals & Reagents | List of all chemicals required for the method |
| Mobile Phase Preparation | Step-by-step procedure including filtration and mixing |
| Chromatographic Conditions | Column details, flow rate, injection volume, detector, oven & autosampler temperatures, gradient program |
| Solution Preparation | SST, QL, standard, and sample solutions |
| Procedure | Injection order and method for blank, SST, QL, standard, and sample |
| SST Acceptance Criteria | System suitability criteria and limits |
| Calculation | Procedure for impurity and assay calculations |
| Typical Chromatograms | Blank, SST, QL, standard, and sample chromatograms |
| Abbreviations | Full names of abbreviations used |
The accuracy and reliability of pharmaceutical analyses depend on a well-prepared STP. Each STP must be carefully reviewed and approved by qualified personnel to ensure reproducibility and compliance.
Related:
Standard test procedure is an Analytical document that contains a detailed analysis procedure of any test
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
Preparation, review, approval and distribution are the different steps of the STP
STP stand for standard test procedure
A Testing procedure is an Analytical document that contains a detailed analysis procedure of any test of the pharmaceuticals
STP is used to perform analysis in R&D, to prepare monograph in QC and to perform technology transfer.
Standard test method contains complete
STPs ensure reproducibility, method validation, and technology transfer across laboratories, reducing errors and maintaining compliance with regulatory standards.
An STP is written by including sections such as approval, safety, chemicals list, mobile phase preparation, chromatographic conditions, solution preparation, procedure, calculation, typical chromatograms, and abbreviations.
Yes, STPs are critical for transferring analytical methods from one site to another, ensuring consistency and compliance.
Include MSDS review, personal protective equipment (PPE) like lab coats, gloves, goggles, and work in fume hoods when necessary.
No, STPs are used for various analytical methods like titration, spectroscopy, dissolution tests, and more.
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