Residues of ethanol, 2-propanol and ethyl acetate were determined by headspace gas chromatography with the use of flame-ionization detector and DB-624 (60 m long, 0.32 mm ID) column. Oven temperature in headspace was 90° C for 30 min.

According to the European Agency for the Evaluation of Medicinal Products it is considered that amount of said solvents in pharmaceutical product must not exceed:

ethanol 5000 ppm

2-propanol 5000 ppm

ethyl acetate 5000 ppm

Validation of the method included: selectivity, specificity, system precision, method precision, intermediate precision, accuracy (recovery), linearity, limits of detection and quantitation (in substance), robustness.

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