Compliance and Documentation

MilliporeSigma’s inorganic reagents and solvents are produced and tested according to multiple international guidelines. This means they can be used worldwide for almost all applications. It also allows our global customers to work with the same standard operating procedures (SOPs) and to export to countries with different regulations. 

By combining multi-standard compliance with comprehensive documentation, our products make your work both simpler and safer.

Multi-standard compliance Learn More

Comprehensive Documentation Learn More

Compliance

MilliporeSigma’s analytical reagents are specified in accordance with various international regulations depending on their quality grade. This way, we make sure their specifications suit the regulatory environment you work in. EMPARTA® is specified according to ACS. Most EMSURE® specifications not only fulfill ACS, Reag. Ph Eur, and ISO guidelines but exceed them – not only by the number of specified parameters but also by lower limiting values. We are regularly adding new parameters and improving our specifications as required by our customers. This is essential as it enables the use of new, more sensitive technologies.

American Chemical Society (ACS)

All EMPARTA® and most EMSURE® products are specified according to the monographs published in the “Reagent Chemicals” guidelines of the American Chemical Society (ACS). We always follow the most recent edition of the guidelines and regularly check for updates. Our in-depth approach to ACS specifications includes comparison with our own stringent quality control standards.

Reagents Section of the European Pharmacopoeia (Reag. Ph Eur)

Most EMSURE® products bear the designation “Reag. Ph Eur” and fulfill the requirements of the European Pharmacopoeia (Ph Eur) published by the European Directorate for the Quality of Medicines & Health Care (EDQM). Ph Eur defines requirements for the “qualitative and quantitative composition of medicines, the tests to be carried out on medicines and on substances and materials used in their production”. It contains a detailed section describing how reagents are to be used for analysis in accordance with the European Pharmacopoeia.

Back to Top

International Organization for Standardization (ISO)

Besides pharmacopoeia regulations, the International Organization for Standardization (ISO) also sets guidelines for analytical reagents. Specifically, ISO 6353 defines the requirements for reagents used in analytical chemistry. All EMSURE® products with the designation “ISO” are compliant with ISO 6353.