Does the EDQM provide the quantitative composition of Ph. Eur. reference standards?

The majority of Ph. Eur. reference standards are pure substances dispatched in small-volume containers. They are for use in control laboratories only.

There are some mixtures and these are identified, for example, as “for system suitability” or “peak identification”. These are usually active substances mixed with impurities potentially occurring in medicinal products on the market. The concentration of the impurities is too low to be considered hazardous to occupational health when used for the intended purpose. Therefore, the EDQM considers the risk based on the main substance and does not provide the quantitative compositions of mixtures on the SDS.

The downstream users are responsible for managing the risks arising from their own uses of the substances.