What Role Do Reference Standards Play in Pharmaceutical Testing?

By Admin December 12, 2025

In the world of pharmaceuticals, accuracy is everything. From development to final approval, every drug must meet strict standards to ensure it is safe, effective, and consistent. At the heart of this entire testing process lies one crucial element: reference standards.

These highly purified, well-characterized substances act as the benchmark against which every batch of a medicinal product is measured.

By comparing unknown samples to these trusted standards, scientists can confidently determine a drug’s purity, potency, and overall quality. Without reliable reference standards from reference standards suppliers in Canada, global acceptance and regulatory compliance would be nearly impossible. This makes them an indispensable tool in modern pharmaceutical testing.

What Are the Types of Reference Standards?

Primary Reference Standard

A primary reference standard is a substance that an extensive set of analytic tests has shown to be authentic material that should be of high purity.

Primary standards can be:

Prepared by independent synthesis
Obtained from existing production material of high purity if there is no other external primary standard available
Prepared by further purification of existing production material or
Obtained from an officially recognized source

Secondary Reference Standard

Next comes the secondary reference standard, which are substances of established quality and purity, usually prepared in-house.

These standards can only be used if they are standardized against primary standards using definitive methods published in national and international standards.

One thing to note is that primary standards should be used in testing wherever economically possible.

Development Reference Standards

At last comes the development reference standards, which are used to support product development if a primary reference standard has not yet been previously established for the material.

What is the Purpose of Reference Standards?

Reference standards are widely used in pharmaceutical laboratories to accurately measure both the purity and concentration of unknown substances.

Primary standards may be utilized for the following purposes:

Standards for chemical intermediates- assays
Potency standards- to support major component assays
Identification standards- to serve as identification comparators
Impurity standards- to support quantitation of minor components
Special use standards- to provide standards for special uses

Secondary standards are usually validated against a suitable primary reference standard and then supplied for routine testing purposes.

Eventually, only one working standard will be approved for a specific use at any time.

The categories of secondary standards are as follows:

Potency standards
Resolution standards
Special use standards
Impurity standards
Identification standards
Chemical intermediate standards

How to Use Standards in Routine Laboratory Analysis?

Before using a reference standard, analysts must check its expiry in the log book. Staff should update records regularly and review expiry dates monthly. Use vials in the order received and keep only one open at a time.

Record the opening date on the label and in the log book. Let standards reach room temperature before use and pre-treat only the needed amount. Store primary standards properly with parafilm and desiccant. Return expired or finished vials for disposal and ensure all details are documented properly.

Final Thoughts

In conclusion, reference standards are essential for ensuring pharmaceuticals’ efficacy, safety, and quality throughout the development process and after we release the products in the market.