Chemtech International

We supplies chemical reference substances (CRS), herbal reference standards (HRS) and biological reference preparations (BRP) as well as reference spectra for the tests and assays to be carried out in accordance with the official methods prescribed in the European Pharmacopoeia. Specific batches of candidate material are selected. These are characterised at the EDQM laboratory according to the principles described in Chapter 5.12. (Reference Standards) of the European Pharmacopoeia and ‘ISO 17034 General requirements for the competence of reference material producers'. Candidate materials can also be the subject of international collaborative studies. Once adopted by the European Pharmacopoeia Commission, official reference standards become available for distribution. They are then used in pharmaceutical analysis, for example, for identification, purity tests or assays according to the corresponding monograph of general chapter of the European Pharmacopoeia.

Specified for use in conducting official tests and assays found in the United States Pharmacopeia–National Formulary, whose standards and procedures are enforceable by the U.S. Food and Drug Administration for drugs marketed in or imported to the United States.
Designed for use in identification tests, limit tests for impurities or related compounds, assays for drug substances and formulations, system suitability tests, chromatographic and spectrophotometric procedures, and performance verification tests (e.g., particle count, melting point, and dissolution) as calibrators, blanks, or controls.

USP currently offers more than 3,500 Reference Standards—highly characterized specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators. USP Reference Standards are specified for use in conducting official USP–NF tests and assays. USP also provides Reference Standards specified in the Food Chemicals Codex as well as authentic substances—high-quality chemical samples—as a service to analytical, clinical, pharmaceutical and research laboratories.


Trust the quality standard that sets the benchmark for medicines worldwide. USP offers official methods, specifications and associated Reference Standards that can help your product meet regulatory requirements and patients’ needs.