Why CRMs are Central to Method Development

Method development is a critical part of manufacturing pharmaceutical products and involves creating an analytical procedure used to evaluate the characteristics of a drug product against regulatory guidelines. The process includes several steps and, if implemented correctly, can ensure a successful drug product from discovery to market. The benefits of a successful analytical method include shorter turnaround times, cost savings, and accurate and reliable testing results. To ensure reliable analytical testing results, certified reference materials (CRMs) are of high importance as they provide a benchmark for accurate and comparable results in laboratories worldwide1. Additionally, CRMs are used for calibrating equipment and quality control applications. In this blog post, we look at why and how CRMs are crucial to method development.

The Importance of Certified Reference Materials

Results obtained from experiments and tests conducted across various scientific fields will be used to determine the next steps in research, product development, and many other applications. As test results have such a significant impact on decision-making processes, which can further affect human health and the environment, it is critical that they are accurate and can be held to specific standards.
CRMs are used as a reference or standard for analytical measurements to ensure the accuracy and reliability of test results. They are high-quality, high-purity materials that have been extensively tested and characterised as a standard for validating test results, the quality and metrological traceability of samples, and calibrating research equipment.

CRMs in Method Development

When a sample needs to be analysed, scientists must have a suitable analytical procedure to accurately test specific characteristics against accepted criteria. Creating an analytical procedure is called method development, which involves selecting a suitable technique and optimal testing parameters, monitoring sample preparation, and validating the method for a particular sample.
CRMs are vital throughout each stage because they will determine if the testing method is accurate and suitable for the chosen sample. This can be conducted by tracing results to the SI reference system to determine the extraction efficiency and check whether the sample is suitable for analysis. CRMs provide a benchmark for analytical testing methods. They are crucial in method development to ensure the most suitable tests are conducted and that they yield accurate and reliable results.

XRF Scientific and Method Development

XRF Scientific manufactures equipment and chemicals for sample preparation applications in construction material companies, production mines, and commercial analytical laboratories worldwide. Our products are used to measure the composition and purity of materials and have high importance in quality and process controls in the chemical, metals, and mining industries.

Sample preparation is a key stage in method development, in which CRMs are used to analyse the method’s repeatability, calibrate instruments, and perform quality control testing. XRF Scientific offers fusion beads and pressed pellets to support scientists in choosing the most suitable devices and tools for their analytical testing methods.

Contact a member of XRF Scientific today to learn more about the importance of CRMs in method development.

References:
https://joint-research-centre.ec.europa.eu/scientific-activities-z/certified-reference-materials_en
https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=928700