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


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.


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


Due to the confidential nature of the material, the content of each monograph is restricted.

You must be logged in to the SPS website with a valid NHS email account to access the stability monographs

Update history

  1. Note added describing restricted access of each monograph
  1. Updated format
  1. Published

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