Accelerated degradation of propyltiohinotiadiazol in stability research

Abstract

INTRODUCTION. Stability research is a key step in assessing the quality and safety of a drug substance. The purpose. Evaluation of the stability of propylthiohinothiadiazole by accelerated isothermal degradation and under stress. MATERIAL AND METHODS. Stability testing methodology ICH Topic Q1A (R2); 3 series of propylthioquinothiadiazole in bulk; Shimadzu LC-20AD liquid chromatograph with UVVIS detector; Perkin Elmer-40 spectrophotometer; thermogravimeter Q200 V24.4 Build 116; solvents, reagents in accordance with the European Pharmacopoeia. RESULTS. Under conditions of oxidative, hydrolytic, thermal, acid-base, photocatalytic stress, it was established by UV-VIS spectrophotometric method that the substance is stable at temperature, humidity and acidic environment. Propylthioquinothiadiazole degrades under the influence of the oxidant and in the basic medium (decreasing the concentration by 3% and 5%). DSC thermal analysis shows that the substance undergoes thermal changes after 1100C. By experimental storage, usingThe results obtained will also be confirmed by real-time stability studies. Currently the substance is stored under normal conditions (25 0C; 65% RH) for 3 years and 10 months. By now, the drug substance meets all the quality criteria set out in the draft of quality specification. "Accelerated degradation" method at 400C and 600C, with the determination of the concentration by the HPLC method, was calculated the shelf life for the substance of 7 years. CONCLUSIONS.