Validated stability data ensures products compounded by cytotoxic reconstitution processes within aseptic units are safe for patients

Purpose

Following the review of stability for cytotoxic drugs for the NHS tender, the cytotoxic monographs are designed to capture the relevant information on stability in a format that is useful for NHS aseptic units.

Aseptic units under Section 10 exemption

Stability data is particularly important to those working in aseptic units 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.

Licensed aseptic units

Extended stability data beyond the maximum seven days that can be assigned under Section 10 exemption 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.

Validity

The studies provided in the monographs have been reviewed against the Standard Protocol for Deriving and Assessment of Stability, Part 1: Aseptic Preparations (Small Molecules), Edition 5, September 2019 (Yellow Cover)

Change history

  1. Updated format
  1. Published