Objective To evaluate the quality profile of losartan potassium tablets in China based on national drug sampling and testing,to assess their safety,efficacy,and potential quality risks,and to provide evidence for improving quality standards along with feasible regulatory recommendations.Method A comprehensive evaluation was conducted on 196 sampled batches using statutory standards combined with exploratory studies,including tests for related substances,moisture,nitrites,nitrosamine,and azide genotoxic impurities.Results The compliance rate under statutory standards was 100%.However,exploratory analyses identified variations in moisture and nitrite levels among products,although genotoxic impurities and related substances were either undetectable or well below regulatory limits.Conclusions Losartan potassium tablets demonstrate satisfactory quality,though existing standards require further refinement by adding moisture and nitrite specifications.

Objective To evaluate the quality profile of losartan potassium tablets in China based on national drug sampling and testing,to assess their safety,efficacy,and potential quality risks,and to provide evidence for improving quality standards along with feasible regulatory recommendations.Method A comprehensive evaluation was conducted on 196 sampled batches using statutory standards combined with exploratory studies,including tests for related substances,moisture,nitrites,nitrosamine,and azide genotoxic impurities.Results The compliance rate under statutory standards was 100%.However,exploratory analyses identified variations in moisture and nitrite levels among products,although genotoxic impurities and related substances were either undetectable or well below regulatory limits.Conclusions Losartan potassium tablets demonstrate satisfactory quality,though existing standards require further refinement by adding moisture and nitrite specifications.

Objective: To develop a model for rapid and non-destructive determination of amoxilcillin sodium and sulbactam sodium for injection using the analysis of near infrared diffuse reflectance spectroscopy (NIR) and chemometrics.Methods: Totally 41 batches of commercial samples and 20 batches of laboratory samples were analyzed by NIR and the legal methods.The first derivative and vector normalization were selected as the preprocessing methods and 8 720-5 446 cm-1 was selected as the frequency range.Results: The quantitative model was constructed based on 16 batches of commercial samples and 15 batches of laboratory samples (0.75 g) and the content ranged from 4.45% to 61.82% for amoxilcillin and 15.75% to 30.25% for sulbactam.The root mean square errors of cross validation (RMSECV), determination coefficients (R 2) and root mean square errors of prediction (RMSEP) respectively was 0.858 , 0.998 1 and 0.936 for amoxilcillin, and respectively was 0.541 , 0.988 1 and 0.423 for sulbactam.The model was tested based on 5 batches of commercial samples and 5 batches of laboratory samples (0.75 g) and the results well met with those of the legal methods with difference ≤ 1.5 %.The model also applied in 10 batches of commercial samples (1.5 g) and 2 batches of samples from the other manufacturers.Conclusion: The non-destructive quantitative NIR methods are accurate with good reproducibility, and applicable for the rapid analysis of amoxilcillin sodium and sulbactam sodium for injection.

Objective:To establish a method for the content determination of pantoprazole sodium for injection by high performance capillary electrophoresis. Methods:The determination was performed on an uncoated elastic quartz capillary column, the running buff-er was 0. 01 mol·L-1 potassium dihydrogen phosphate buffer, the running voltage was 25kV,the column temperature was 25℃ and the detection wavelength was 289 nm. Results:The linear range was good within the concentration range of 20. 05-200. 51 μg·ml-1(r=0. 999 6). The average recovery was 99. 03%(RSD=0. 86%, n=9). Conclusion:The method is simple, sensitive and reproduci-ble, and can be used in the determination of pantoprazole sodium for injection.