Objective  To investigate the impurities of ganciclovir for injection and its raw mate-rials, and compare the impurities among different batches of raw materials and preparations. Meth-ods  The HPLC method was performed on an CAPCELL PAK SCX UG80 column (250 mm×4.6 mm, 5 μm), the mobile phase was 0.05% trifluoroacetic acid solution-acetonitrile (50 : 50) at a flow rate of 1.5 mL·min^-1, the detection wavelength was 254 nm, the column temperature was 40℃, and the injec-tion volume was 20 μL. The source of impurities was discussed by means of degradation test, stress test, and accelerated test. The structure of impurities exceeding 0.1% was analyzed by mass spec-trometry, and their toxicity was evaluated by toxicity prediction software.

Results  The impurity spectrum of ganciclovir showed that a total of 19 impurity peaks were detected, 5 were known impu-rities and 14 were unknown impurities. The structures of 5 impurities with content greater than 0.1% were analyzed. Degradation test showed that ganciclovir was easier to degrade under oxidative or acidic conditions. The impurity spectrums of raw materials and preparations are different between different enterprises, and the impurity spectrums of different batches of raw materials in the same enterprise are also different. The related substances in preparations were mainly derived from raw materials and the production process of preparation enterprises is relatively stable. Compared with the reference preparation Cymevene, the impurity profiles of the domestic products were more com-plex.

Conclusion  Ganciclovir raw material enterprises should strengthen the control of the stability of the production process, strengthen the control of the content and number of impurities in the product, and optimize product quality.

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