Stability assessment of Teicoplanin infusions in 0.9% sodium chloride in various infusion devices

J. Holden Quality Control North West, Stepping Hill Hospital, Stockport, UK

Introduction

Teicoplanin is a complex antibiotic which comprises of six closely related glycopeptide subcomponents. [1] These components are named A3-1 and A2-1 to A2-5 as defined in the European Pharmacoepia. [2] The degradation pattern of teicoplanin is understood to include conversion of A2 subcomponents to the A3 group and is estimated to be around 5%. It is also now known that all components contribute to the action of the antibiotic and therefore analysis of the resulting chromatogram as a whole is important when assessing stability of this molecule. [1]

Aim

To determine the shelf life of Teicoplanin infusions using a two strand assessment of stability. This assessment is based on both an assay of the main peak (A2-2) and alterations to the starting composition of the product across the stability study. This will be carried out using 0.9% sodium chloride as the diluent at a range of concentrations stored in non-PVC bags and also in Baxter SV200ml/hour infusion pumps. In addition, for the infusion pumps a method of comparing the overall composition of group A2 and A3 will be used based on recommendations from an EMA report on Teicoplanin.

Methods

Samples were prepared in house for both containers replicating clinical practice as closely as possible. The devices were stored at 5 and 25°C and sampled at set time points up to 28 days (infusion pumps) and up to 84 days (infusion bags) analysed using HPLC, pH, visual examinations and sub-visible particles.

Conclusion

The study reports a recommended shelf life for Teicoplanin infusions between 4 and 8 mg/ml when stored in polypropylene infusion bags and Baxter Intermate SV200ml/hour infusion pumps. Short term storage at room temperature is also reported.

[1Assessment Report : Teicoplanin, European Medicines Agency, Procedure No : EMEA/194668/2013, March 2013

[2European Pharmacopeia 8.0

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