Monitoring residual solvents in pharmaceutical products using a portable pre-concentration GC-PID.

Pharmaceutical manufacturing utilizes solvents at different stages of production. Some of the harmful solvent residuals may be retained in the final product; therefore, they need to be monitored for quality control and to meet the regulation requirement. Here, a novel method capable of rapidly analyzing residual solvents in pharmaceutical products was developed using a compact-portable gas chromatography with a photoionization detector (GC-PID). The method consists of modified Tedlar® bag sampling, online pre-concentration, separation of volatiles by miniaturized GC, and micro-PID detection. The method detection limits of selected residual solvents were in the range of 26.00 - 52.03 pg/mL which is much lower than the pharmaceutical compliance concentration limits. Limits of detection > 520 pg of analyte per grams of sample was also determined for the over-the-counter drugs. The method performance showed rapid speed (5 min), linear calibration (r2 < 0.99), and repeatable retention time (RSD < 0.4 %). Direct analysis of residual solvents in solid samples was conducted without the need for complex sample preparation. The method validation using over-the-counter pharmaceutical products yielded excellent accuracy (recovery > 91.2 %) and precision (RSD < 6.5 %) for the selected residual solvents, including 1,4-dioxane, benzene, chlorobenzene, cyclohexane, xylenes, and toluene. This portable and rapid method could be deployed during the pharmaceutical drug manufacturing processes for quality control.

Analyzing Readmissions Patterns: Assessment of the LACE Tool Impact.

This paper will discuss the assessment of the use of the LACE tool at North York General Hospital (NYGH). The LACE tool estimates the readmission risk of patients. This paper describes the tool and a modified LACE score implementation and use at NYGH. We also describe our statistical analysis for the LACE effectiveness in order to inform future decisions in resource allocations. We will look at suggestions for adjustments in the way the LACE tool is used as well as implications for service delivery and patients' quality of life. Our study shows that the modified LACE is a predictive tool for readmission risk in day-to-day hospital activity, but that implementation of LACE alone cannot reduce readmission rates unless coupled with efforts of those in charge of providing community-based care.