Pemetrexed: Cytotoxic Drug Stability Monograph

Kathryn DaviesPublished Last updated See all updates

Stability information is essential for the safe aseptic preparation of Pemetrexed.

Following the review of stability for cytotoxic drugs for the NHS tender, these monographs are designed to capture the information in a format that is useful for NHS aseptic units, particularly those working under Section 10 exemption with restricted shelf lives for products. There is also, where applicable, a view on the extended data beyond the maximum seven days that can be assigned under Section 10 exemption. This may be of use to licensed NHS aseptic units and also to procurement staff in terms of assessing the shelf lives assigned by commercial aseptic compounding units.

The studies provided have been reviewed against the standards of the NHS standards for stability testing of small molecule drug aseptic products

Attachment for pemetrexed

Other cytotoxic drug stability content

Change history

  1. Update from V2 due to additional study report available from Accord.
  1. Includes some extended stability data for the new Accord formulation for Pemetrexed (now a concentrate for solution for infusion)
  1. Published