Abstract: Objective To study the quality consistency between generic drugs and reference drugs of omeprazole sodium for intravenous injection by comparing the data on the crystal form, impurity profiles and other standard tests. Methods Thirty-three batches of omeprazole sodium for intravenous injection (40 mg) produced by seven enterprises were tested. The crystal form was studied using the X-ray powder diffraction method. Related substances, alkalinity, clarity and color of solution, water content, weight uniformity, visible particles, insoluble particles and assay were determined according to the standards specified by Chinese Pharmacopoeia (2020 edition). Data was statistically processed using SPSS software. Results Generic drugs and reference drugs were both amorphous powders. The crystal form of omeprazole sodium from three enterprises was the same as that of reference drugs, but different from that of omeprazole. The generic drugs were not significantly different from reference drugs in impurity profiles, but significantly different from reference drugs in alkalinity (1 enterprise), color of solution (4 enterprises), water content (2 enterprises), average weight (4 enterprises) and content (1 enterprise). Only the generic drugs produced by one enterprise were not significantly different from reference drugs in the prescription, crystal form and test data. Conclusion Only the generic drugs produced by one enterprise are of the same quality as reference drugs, which suggests that enterprises should improve its product quality by improving its production process.

Key words: omeprazole, consistency, crystal form, impurity profile, quality