Pharmacopeia & Metrological Institute Standards

Products

USP Standards

The United States Pharmacopeia is an independent, not-for-profit, nongovernmental pharmacopeia. Through their published monographs, the USP sets internationally recognized quality standards in the USP-NF reference text. To support testing according to the monographs, USP maintains an ever-growing catalog of highly characterized Reference Standards for thousands of APIs and Related Compounds..

Ph. Eur (EP) Standards

The European Directorate for the Quality of Medicines & HealthCare (EDQM) publishes drug safety/purity standards in the European Pharmacopoeia (Ph. Eur.). EDQM offers a growing portfolio of over 3,000 Chemical Reference Standards (CRS) including many rare impurities not available through any other source.

BP Standards

The British Pharmacopoeia (BP) sets quality standards for UK pharmaceutical substances and medicinal products. Used in over 100 countries, the BP has a wide reach and collaborates with other leading pharmacopoeias as well as the World Health Organization (WHO). British Pharmacopoeia Chemical Reference Substances (BPCRS) primary standards are available for a broad range of compendial applications and can be conveniently ordered in one place together with the rest of your analytical workflow.

NIST Standards

Founded on March 3, 1901, the National Institute of Standards and Technology (NIST) in the United States is one of the oldest physical science laboratories globally. Its measurements support the smallest of technologies to the largest and most complex of human-made creations. NIST standards, also called standard reference materials (SRMs), are available for use in various areas such as industrial raw materials, clinical chemistry, environmental analysis, and food and agriculture.

JRC

Joint Research Centre (JRC), before known as Institute for Reference Materials and Measurements (IRMM), supports the European Union (EU) policies with scientific advice on measurements and standards by the development of reference methods or certified reference materials. The reference materials of the European Commission’s Joint Research Centre cover several product categories such as food matrix materials,  genetically modified organisms (GMOs), polycyclic aromatic hydrocarbons, clinical matrix standards, physical properties among others.

NRC Canada

NRC Canada′s certified reference materials (CRMs) are traceable to the International System of Units, and conform to the requirements of ISO/IEC 17025 and ISO 17034. For specific values, as well as additional information regarding stability and storage information, please view the Certificate of Analysis. With NRC Canada′s CRMs, you gain access to products backed by extensive research and expertise, fostering trust and consistency in your results. Elevate your laboratory′s accuracy and credibility with NRC Canada′s certified reference materials.

The portfolio includes biotoxins (mycotoxins, marine toxins and cyanotoxins), food matrix materials, stable isotope labelled standards, amino acids and many others.

The N-alkylpyridinium-3 sulfonates mix RM-RILC serves for standardization of retention times across different conditions. This technology is patented by NRC Canada. 

METAS

The Federal Institute of Metrology METAS serves as the federal centre of competence for all issues related to measurement and for measuring equipment and procedures. It is the Swiss national metrology institute. As such, its mandate is to ensure the availability of measurement and testing facilities with the degree of accuracy needed to meet the requirements of the economy, research and administration. In collaboration with us in Buchs, METAS is developping certified reference materials. An example is the Whey Protein Matrix Material WP-CBR001, intended to be used for development, validation and performance control of analytical methods for the determination of toxic elements and polycyclic aromatic hydrocarbons (PAHs). 

Secondary Pharmaceutical Standards

Our selection of secondary pharmaceutical standards includes CRMs certified under ISO/IEC 17025 and ISO 17034, offering multi-traceably to primary standards from pharmacopeias such as USP, Ph. Eur, and BP. Paired with compendial (primary) standards, secondary standards serve as a convenient and cost-effective alternative to the preparation and qualification of in-house working standards and can help greatly streamline your analytical workflow. These pharmaceutical secondary standards have applications in raw material QC, in-process testing and finished good release. The accompanying certificate of analysis is ISO 33401:2024 (formerly ISO Guide 31) compliant, including certification details and certified purity values, allowing the use of the standard by ISO/IEC 17025 accredited laboratories for applications outside of compendial monographs.