Procaine hydrochloride solution for injections stability studies, technology and quality evalution.

The aim of the study: To assess the technology of injection solution of drug Procaine hydrochloride, to measure quality and quantity and determine the expiry day of this drug. Objectives: 1. To design the stability trials protocol of injection solution of procaine hydrochloride. 2. To design specification of this drug 3. To select and adjust methods for stability evaluation. 4. To assess the results of stability tests while holding drugs in different stress conditions, give recommendations. Conlusions: 1. Created testing protocol let perform stability tests and confirm right conclusions about procaine hydrochloride injection solution quality. Also reliably determine drug expiry time. 2. Up created procaine hydrochloride 1% and 0,5% drugs specification let reliably evaluate drug products quality. 3. For procaine hydrochloride injection solution drugs stability evaluation were selected in Ph.Eur. described methods. For drugs quantity evaluation – UPLC method was successfully validated and this let determine drug from his degradation product too. Validation proved this method suitability for products stability evaluation. 4. Stability trials results showed that 1 percent and 0,5 percent concentration procaine hydrochloride injection solution are stable for not less than 6 months holding them in 25 ±2 °C temperature and 60 ±5 percent humidity conditions. Holding procaine hydrochloride injection solution in 40 ±2°C temperature and 75±5 percent humidity 0,5 percent injection solution were stable for 3 months, and 1 percent concentration injection solutions were stable for 4 months