Based on the fastest degradation rate observed, with 95% confidence, this study has demonstrated that solutions of norepinephrine, diluted in NS or D5W to a concentration of 64.5 mg/L and stored for 60 days with protection from light at 4°C and then at room temperature for an additional 24 h, will retain more than 95% [...]

Accelerated Degradation and Assay Validation Degradation of norepinephrine with heat and base (pH 8.264) occurred relatively quickly, such that less than 1% of the initial norepinephrine concentration remained after 37 min. As the norepinephrine concentration decreased, degradation products eluted at 1.3, 1.7, 2.1, 2.5, 2.8, and 4.8 min. These degradation products were well separated from [...]

Stability Study On study day 0, 4 mL of a 1 mg/mL solution of norepinephrine (norepinephrine bitartrate injection USP, Sandoz Canada Inc; lot 149812, expiry April 2010) was with­drawn from a vial and further diluted in a 50-mL polyvinyl chloride (PVC) minibag of 5% D5W (Baxter Corporation, Mississauga, Ontario; lot P230821, expiry June 2010) to [...]

Liquid Chromatography The liquid chromatographic system consisted of an isocratic solvent delivery pump (model P4000, Thermo Separation Products, San Jose, California), which pumped a mixture of acetonitrile (OmniSolv; EMD Chemicals Inc, Gibbstown, New Jersey) and 0.05 M phosphoric acid (catalogue no. P286; Fisher Scientific, Toronto, Ontario) containing 1 mg/mL of heptane sulfonic acid (catalogue no. [...]

INTRODUCTION The expiry date of medications intended for IV administra­tion following reconstitution or dilution is often limited to about 24 h, even when data on extended stability exist, because of the potential for breaks in sterility and contamination of the product. However, when reconstitution and dilution are carried out in a sterile environment, based on [...]

Because only small changes in clozapine concentration could be detected under the storage conditions studied, assurance of the specificity of the analytical method is very important. In addition, the separation and detection of intact drug in the presence of degradation compounds must be assured before the method can be considered suitable for indicating stability. The [...]

During the study period, the concentration of clozapine observed in all study samples remained within 5% of the initial concentration. Multiple linear regression detected a significant (p = 0.0379) trend for a change in concentration over the study period, but the change averaged only 2.56%. There were no significant differences in the rate of clozapine [...]