4 Frequently Asked Questions About Reference Standards

Chemical reference standards, often known as reference standards, are highly purified substances used in experiments and research. They are used to determine qualitative and quantitative data and calibrate instruments. Thus, the purity and quality of reference standards play a crucial role in ensuring the efficacy and safety of the substance, products, or experiments.

This is it for a brief intro to reference standards. Let us now answer some frequently asked questions that will help you better understand the characterized substances.

How Often Must Reference Standard Materials be Retested?

Several factors influence the need to retest reference standard materials. It primarily depends on the use case and characteristics of the material that is being tested. Please note that the retest frequency must be backed by data obtained during stability studies.

Since the identity of impurity and reference markers is most crucial, reevaluating their purity over a short period is not that important. Therefore, you can generously determine the retesting duration.

When are Secondary Reference Standards Used?

Using secondary reference standards requires careful planning as they must hold qualifications against primary standards. Secondary standards are often used in the absence of compendial standards to prevent unnecessary problems or delays associated with the program.

How Pure Should Reference Standards be?

Regulatory bodies such as the U.S. FDA (Food and Drug Administration) indicate purity of reference standards as “highly purified compounds.” However, they do not state a particular value, often leaving people confused when it comes to measuring the standard’s purity.

In the case of reference materials, the purity of the substance depends on the type of material being used since all the materials have different natures and purity values. Regardless of the purity, using relevant techniques is a must to characterize reference materials.

How Do You Manage Reference Standards?

It is best to use dedicated software to manage high-quality reference standards. The relevant and custom software will help authorities track standard test dates, generate a certificate of analysis, and move the entire data through a review process. You may need to develop custom software solutions and other operating procedures according to the program’s complexity.

The Ending Note!

Reference standards are highly purified substances affecting the tests’ or other products’ efficacy and safety. So, maintain them and source them from reliable pharmaceutical reference standard suppliers.