Drug stability data now available for up to 18hr administration of Ceftazidime

Accufuser® Elastomerics Pump: Drug stability data now available for up to 18hr administration of Ceftazidime

In order to assign a shelf life to a prepared product in an elastomeric device, comprehensive stability tests must be completed.

NHS standards, known as the Yellow Covered Document (YCD) stipulate the minimum testing requirements before an expiry date can be given.

These include:

  • Testing temperature requirements: 32°C +/- 1°C for in-use ‘near to body studies’ (for elastomeric devices and similarly insulated devices)
  • A concentration of 95-105% of active pharmaceutical ingredient must be present at the end of infusion
  • All samples tested in duplication
  • Low and high ‘clinically significant’ concentrations
  • Complete physical stability testing e.g. colour, clarity, precipitation, pH
  • Three samples at each time point
  • At least four time points plus time zero
  • Use of a stability indicating assay e.g. HPLC.

We can now confirm that the YCD drug stability data specifically for Ceftazidime is now available.

To request the full stability protocol simply click the link and fill in your details:

 

Request Protocol

For More Information Contact Us

General Enquiry

Section

Section

reCAPTCHA