A revised version of the monograph on Betacarotene (1069) published in Supplement 9.7. of the European Pharmacopeia (Ph. Eur.) has entered into force on 1 April 2019. This revised monograph requires the use of two new CRSs: Betacarotene CRS and Betacarotene for system suitability CRS.
These new CRSs are expected to become available by the end of April. Until then, and in order to ensure a continuous supply of betacarotene in Europe, concerned Ph. Eur. users needing to release their batches can do so by complying with the previous version of the monograph as published in Edition 9.0.
The EDQM will publish updated information on its website when the two new CRS are available for order.