Extended stability study of an extemporaneously analgesic solution of clonidine, ropivacaine and fentanyl

Abstract The aim of this work was to perform an extended stability study for the analgesic containing fentanyl, clonidine and ropivacaine in physiological saline solution 0.9% at different infusion sites, such as infusion bags, epidural infusion sets and syringes. The extended stability was assessed by an HPLC system equipped with a photodiode array detector set at 210 nm. The separation was conducted on a C18 column maintained at 40˚C and using an isocratic mobile phase consisted of buffer solution-methanol-acetonitrile (45:45:10, v/v/v). The presence of particulate matter and the pH of each solution were also investigated. Twenty-four hours after the preparation, the formation of one suspected product was observed and for all drugs, in 24 hours it was observed the concentration decrease in different sets (PVC infusion bags, syringes and epidural infusion administration sets). The pH values of each solution varied no more than 5% during the study and no particle was observed. Conclusion: The extended stability study was applied to the analgesic solution and promoted the detection of an unexpected peak in 24 hours. Based on it, further stability studies are necessary to determine the extended stability data.

The Extended Stability of Cervical Swabs in careHPV™ Collection Medium

@#Introduction: The careHPV™ Test is a US FDA approved, CE mark, and WHO prequalified in vitro diagnostic test designed to screen for 14 high-risk human papillomavirus (HRHPV) genotypes. The careHPV™ Test is one of the commercial HPV test validated to be used in low resource settings, boasting the economy of processing a maximum of 90 samples per batch and a near point-of-care turnaround time of 3 hours. According to the manufacturer, cervical swabs stored in careHPV™ Collection Medium are stable for 30 days when stored between 2-8°C. However, we often had difficulty consolidating enough samples for a full batch-test within 30 days, especially when screening women living in the low-density villages in rural Sarawak, Malaysian Borneo. This study aimed to evaluate the stability and repeatability of cervical swabs preserved in careHPV™ Collection Medium stored at 4°C exceeding the recommended 30 days using the careHPV™ Test. Methods: Two groups of confirmed HRHPV-positive and HRHPV-negative cervical swab samples in careHPV™ Collection Medium consisting of 4 samples each were maintained at 4°C and tested using the careHPV™ Test at Day -38, -123, -131, -223, and -395. Results: All cervical swabs in the careHPV™ Collection Medium stored at 4°C remained stable for testing and demonstrated 100% repeatability for at least 395 days from the day of collection. Conclusion: The careHPV™ Test can be successfully performed on cervical swabs preserved in careHPV™ Collection Medium, which were stored at 4°C for at least 395 days.