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Physical & Chemical properties

Stability in organic solvents and identity of relevant degradation products

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Description of key information

The test item was found to be stable in ethanol and isopropyl alcohol at 4 degree C and 20 degree C for at least 28 days.

Additional information

A study was conducted to determine the stability in organic solvents. Therefore the test item was prepared and stored at 4 degree C and 20 degree C in ethanol and isopropylalcohol. Two replicate samples of the test solution per solvent, two blank samples per solvent and two additional reserve samples per solvent were prepared. The concentration of the test item in the test solution was monitored at the start of the storage and after different storage periods. An aliquot of each test sample was taken after 0 hours, 24 hours 7, 14, and 28 days. The concentration of the test item was determined using HPLC-UV method. The mean concentration of the test item in ethanol was determined to be 1044.7 mg/L and in isopropyl alcohol the mean concentration was determined to be 1047 mg/L. The over all mean concentration of the test item in both solvents over a period of 28 days was determined to be 1047.0 mg/L. No degradation of the test item was observed. The concentration of the test item was constant during the test period. Thus, the test item is regarded as stable in organic solvents.