Background Hospital pharmacies produce a range of preparations for hospital use. Among these are injectable heparin formulations as ready to use preparations, for patient safety.
On 1 January 2015 a new assay for heparin was adopted in the European Pharmacopoeia and implemented in our QC, and evaluation of the stability of the products was performed. There is a need for solid data on the stability of our products as published data are rarely reported1.
A substantial saving was expected when the assay was carried out by us compared with the costs from an outside laboratory used previously.
Purpose To implement the Ph Eur heparin assay and to establish data for loss of heparin potency due to autoclave sterilisation.
To reduce costs.
Material and methods The assay was carried out paying close attention to the description in the monograph. The need for update in the statistical evaluation of the results was observed and reported to Ph Eur.
The assay was carried out using a robot ACL TOP 300 from Internat Lab Services, USA.
Reagents were from Provision Kinetics, Arlington, Wisconsin, USA.
Heparin sodium BRP was used as standard in the assay and in the test for accuracy.
Heparin IV solutions were formulated without preservations; WFI and sodium chloride were only added.
Results Accuracy for the assay was 100.1% (SD 0.9%), n = 6.
Repeatability (5000 IU/mL) measured as SD was 1.0%, n = 12.
Potency of ‘heparin 100 IU/mL’ before autoclaving was 108 IU/mL and after autoclaving 95.6 IU/mL, both n = 5, equivalent to a 11% decay in potency. The total lethality of the autoclaving, Fo, was 34 at 120oC.
The cost reduction was estimated at 75 000€/year. Final data will be presented in the poster.
Conclusion Implementation of the new assay of heparin in the Ph Eur was carried out according to the plans, and acceptable statistical values for the assay were obtained.
The activity of heparin IV solution was reduced by 11% due to autoclaving, giving rise to considerations about thermal treatment and heparin excess.
References and/or Acknowledgements
Beaudet JM, et al. Impact of autoclave sterilization on the activity and structure of formulated heparin. J Pharm Sci 2011;8:100
References and/or AcknowledgementsNo conflict of interest.
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