Baxter Healthcare (Manufacturing Authorisation (MIA) holder for Cyclophosphamide Injection) has revisited the stability data for the ready-to-administer product in syringes and infusion bags. A new study was carried out to the standards outlined in ‘A Standard Protocol for Deriving and Assessment of Stability Part 1 – Aseptic Preparations (Small molecules)’1. Aligned with this protocol, the study also included analysis that degradation product levels remained within the limits of the Marketing Authorisation for the licensed dry powder product.
One of these degradation products exceeded the acceptable limits before 5% of the active ingredient was lost in this study and hence has become the shelf life limiting factor for the ready-to-administer product. Following discussions between Baxter and the MHRA, this has led to a reduction in the shelf life for ready-to-administer cyclophosphamide injection from up to 84 days to 25 days (2-8C) followed by 6 hours at room temperature to allow for administration, or 21 days (2-8C) followed by 12 hours at room temperature.
Clinical Governance & Technical Services Specialist, Specialist Pharmacy Service