Impurity Standards refer to known impurity substances used as reference materials during analytical testing. They are commonly used to verify, calibrate, or identify the impurity content in samples, ensuring the accuracy and reliability of the analytical results. The composition and concentration of impurity standards are strictly validated and generally comply with international or industry standards, such as those set by the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and International Pharmacopoeia (ICH).

How Are Impurity Standards Used Across Industries?

Pharmaceutical Industry

In the pharmaceutical industry, impurity standards are used to detect impurities in active pharmaceutical ingredients (APIs) and finished products. These impurities may be by-products generated during the synthesis process and must be within specified limits to ensure the safety and efficacy of the medication.

Environmental Testing

In environmental monitoring, impurity standards are used to detect pollutants in water, air, and soil. These standards help identify harmful substances in environmental samples and ensure compliance with environmental protection regulations.

Food and Beverage Industry

The food industry also relies on impurity standards to ensure the safety of products. Whether it's detecting pesticide residues, heavy metals in food, or ensuring that no non-compliant additives are present during production, impurity standards are crucial.

What Types of Impurity Standards Are Available?

Impurity Standards play a crucial role in analytical testing and quality control, and they are mainly divided into two categories: Certified Reference Materials (CRMs) and Custom Impurity Standards.