RationaleStress testing on tinoridine hydrochloride was carried out using a multidimensional approach. This included different conditions: hydrolytic (acidic, alkaline, and neutral conditions), different oxidative reagents, thermal, photolytic conditions, HPLC method development, and structural elucidation using high‐resolution mass spectrometry (HRMS). It provides the basis for quality control of tinoridine hydrochloride and its derivatives during storage conditions.MethodsThe tinoridine hydrochloride was subjected to a variety of stress conditions. A gradient reversed‐phase HPLC method was developed on a X‐Bridge C18 column (250 × 4.6 mm, 5 μm) to separate all the degradation products (DPs). HRMS studies have been performed to elucidate the structure of DPs.ResultsHPLC‐PDA study revealed that significant degradation products were formed in hydrolytic, AIBN (radical initiator at 40°C), thermal, and solid‐state photolight stress conditions, but the drug was stable under oxidative conditions (H2O2, Fenton's reagent at room temperature and ferric chloride at 40°C). The structure of degradation products was elucidated, and mechanism of their formation was explained.ConclusionStress study was successfully carried out as per ICH Q1A (R2) guideline on tinoridine hydrochloride. A total of six new degradation products were characterized, DP 2 and DP 6 formed by the effect of co‐solvent. This study provides the scientifically sound basis for quality monitoring and storage conditions of tinoridine hydrochloride.