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| Investigation on the stability of the Penicillin Sodium skin test solution under the modified preparation method |
| WAN Xia1 PAN Jing2 XIAO Wei3 ZHANG Yong1 WANG Huibing4 |
1.Department of Pharmacy, Nanjing Children's Hospital of Nanjing Medical University, Jiangsu Province, Nanjing 210008, China;
2.Department of Quality Management, Nanjing Jinling Pharmaceutical Factory, Jiangsu Province, Nanjing 210038, China;
3.China Pharmaceutical University Pharmaceutical Co., Ltd., Jiangsu Province, Nanjing 210009, China;
4.Department of Outpatient, Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School, Jiangsu Province, Nanjing 210008, China |
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Abstract Objective To investigate the changes of related substance of Penicillin Sodium skin test solution after keeping at 2-8℃ environment for 4 h, in order to guide the use of Penicillin Sodium for injection. Methods High performance liquid chromatography was used to analyze the samples of Penicillin Sodium. The Red Classical C18 chromatographic column (5 μm, 150.0 mm×4.6 mm) was adopted, phosphate buffer, methanol and acetonitrile were used as mobile phase, with the flow rate of 1.0 mL/min. The detecting wave length was set at 225 nm, the column temperature was 34℃ and the injection volume was 20 μL. Results The content of impurities in Penicillin solution would increase after acid or base destruction and the new impurities would appear, while there were no new impurities appeared in the Penicillin solution after storage for 4 h. The content of impurity F in skin test solution of Penicillin Sodium samples had no significant changes before and after storage, while the contents of impurities A, B, C, D, E had certain changes, but the total content of impurities was not more than the corresponding main area of the control solution. Conclusion The modified preparation method simplifies the preparation process. The content of related substance of Penicillin Sodium skin test solution will increase after keeping for 4 h at 2-8℃, which increase the possibility of false positive result, therefore, Penicillin Sodium should be used during shorter time.
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