Residues of methanol, ethanol, acetone, dichloromethane, hexane, ethyl acetate, tetrahydrofuran, pyridine and toluene 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 100 °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:

methanol 3000 ppm, ethanol 5000 ppm, acetone 5000 ppm, dichloromethane 600 ppm, hexane 290 ppm, ethyl acetate 5000 ppm, tetrahydrofuran 720 ppm, pyridine 200 ppm and toluene 890 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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