Reference standards in the pharmaceutical industry refer to the foundation of analytical methods that are used for the safety, quality, and potency assessment of medicinal products during their entire course of development and market life.

Please note that each of your medicinal products should have a unique reference standard so that you can constantly compare and test the products to ensure they are readily accepted globally. Overall, reference standards refer to samples of reported impurities, drug substances, compendial reagents, excipients, degradation products, and USP performance calibrators. In the pharmaceutical industry, they are used to assess the purity and quality of standards that will be used for medicinal and healthcare products.

Types of Reference Standards

Pharmaceutical laboratories generally use two reference standards, namely primary and secondary reference standards, to conduct their tests. Let us look into each of them briefly.

Primary Reference Standards

Primary or master reference standards refer to materials that have achieved the status of high purity after passing several analytic tests. Regulatory bodies or agencies and several pharmacopeias recognize these high-purity materials as the formal industry standard for specific tests. Some things to note about these standards are;

• Independent or unconventional synthesis can result in master standards.
• These high quality reference standards are generally acquired from authorized sources.
• The existing material is further purified to achieve desired quality standards.
• In case the external primary standard materials are unavailable, the current high-purity production material is used.

Secondary Reference Standards

Secondary or working reference standards are materials prepared domestically. These pure and quality materials are used only if they match standard requirements based on some definitive practices authorized by international and national standards and pharmacopeias.

Please note that according to the thumb rule, primary standards, wherever economical, will be used for testing over the secondary standards.

Development Reference Standards

These reference standards are unique and mainly support the development of products in case the primary reference standard for particular materials has not been established. These standards can be a part of the reference standard program in case the developing firm considers the request.

Why is Reference Standard Important for the Pharmaceutical Industry?

Pharmaceutical labs use reference standards for determining a material’s purity and concentration of unfamiliar substances. Primary standards can also be used to support the evaluation of principal components, estimate the number of minor elements, evaluate standards for chemical intermediaries, and deliver materials for specific use cases. Lastly, it can function as an identification comparator.

On the contrary, secondary standards are used for general purposes and will have one approved working standard for certain use. These are categorized into potency, resolution, chemical intermediate, identification, special use, and impurity standards.

Do You Need Reference Standards?

Only an authorized source or sources will manufacture and test primary and secondary reference standards to comply. So, choose a trusted supplier for your primary, secondary, and chemical reference standards requirements.