TOPICS : 02- QUALITY, SAFETY & ENVIRONMENT  / 07. 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, which are identified, for example, for system suitability or peak identification. They 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 for the intended purpose. Therefore, the EDQM considers the risk based on the main substance and does not provide on the SDS the quantitative compositions of mixtures.

The downstream users have the responsibility to manage the risks arising from their own uses of the substances.

I'd like to contact the EDQM for further information. Click here

The last 15 days
Search the exact sentence