Analytical method validation for the quality control and stability study of hospital preparations: Why and how?

International audienc

Physicochemical stability of norepinephrine bitartrate in polypropylene syringes at high concentrations for intensive care units

International audienceOBJECTIVES:Norepinephrine is usually used in emergency situations such as in intensive care units (ICUs) for the restoration of blood pressure. The objective was to study the stability of highly-concentrated solutions of norepinephrine at 0.50mg/mL and 1.16mg/mL, diluted in glucose 5% (G5%) in polypropylene syringes, protected or not from light, up to 48h.MATERIALS AND METHODS:Chemical stability was analysed by high-performance liquid chromatography coupled to photodiode array detection at each time of the analysis. The method was validated according to the International Conference on Harmonisation Q2(R1). Physical stability was evaluated by visual and subvisual inspection. Three syringes for each condition were prepared. At each time of the analysis, three samples were analysed for each syringe. pH values were evaluated at each moment of the analysis.RESULTS:Solutions of norepinephrine at 0.50 and 1.16mg/mL, diluted in G5%, with or without protection from light, retained more than 95.0% of the initial concentration after a 48-hour storage at 20-25°C. No visual and subvisual modification occured during the stability study. No degradation product appearing during the stressed degradation was observed during the study but an additional peak with a relative retention at 0.66 was observed and constant. This peak was identified as 5-hydroxymethylfurfural, a degradation product of glucose.CONCLUSION:Norepinephrine diluted in G5% at 0.50mg/mL and 1.16mg/mL was physically and chemically stable over a period of 48hours at room temperature. These stability data of highly concentrated solutions provide additional knowledge to assist intensive care services in daily practice

First international database of research teams in stability and compatibility of medications: An additional function in the Stabilis® database

International audienc

Interrelationships Between Wild Boars (Sus scrofa) and Truffles

The European population of wild boars has increased considerably since the 1960s, leading to increased damage to agroecosystems. Their distribution coincides with the natural distribution of the most important commercial Tuber species. In this chapter, the truffle/wild boar interrelationships are discussed and include the importance of truffles in their diet, their role in spore dispersal, and their impact on cultivated truffières. Wild boars eat a wide variety of foods: plant matter, animals, fungi, bulbs, tubers, and roots. Analyses of their feces and stomach contents suggest they can be considered casual or opportunistic mycophagists, with fungal consumption simply dependent on the availability of other foods. The ingestion of hypogeous fungi is more frequent than that of epigeous mushrooms. Their rooting behavior primarily reduces plant cover and diversity, affects the first 15–70 cm of the litter layer, and can damage up to 80 % of the forest soil surface. Excavation may cause great economic losses to cultivated truffières, not only in terms of truffle predation but also through soil disturbance so that there can be significant increases in truffle production after fencing cultivated truffières damaged by wild boars. Because wild boars can move as much as 15 km in a day, they efficiently contribute to long-distance dispersal of truffle spores. Moreover, the action of the degradation of the digestive enzymes on asci and spore wall improves germination and the ability to form ectomycorrhizas and results in wild boars playing a pivotal role in truffle colonization of new habitats