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格隆溴铵注射液在聚丙烯注射器中于室温及4℃下的稳定性。

Stability of glycopyrrolate injection at ambient temperature and 4 deg C in polypropylene syringes.

作者信息

Storms Meredith L, Stewart James T, Warren Flynn W

机构信息

Department of Pharmaceutical and Biomedical Sciences, College of Pharmacy, University of Georgia, Athens, Georgia.

出版信息

Int J Pharm Compd. 2003 Jan-Feb;7(1):65-7.

Abstract

The stability of 0.2-mg/mL glycopyrrolate injection in 6-mL polypropylene syringes stored at ambient temperature and at 4 deg C for up to 90 days was investigated. A high-performance liquid chromatographic stability-indicating assay was used to determine the concentration level of glycopyrrolate injection 0, 1, 4, 7, 15, 30, 45, 60, and 90 days after preparation of the syringes. Benzyl alcohol, which was added as a preservative, did not interfere with the assay. The injection in plastic syringes was stable for up to 90 days at both ambient temperature and at 4 deg C. The pH of the glycopyrrolate injection did not change appreciably during the 90-day study period. These data indicate the stability of glycopyrrolate injection under the storage conditions investigated in this study.

摘要

研究了在室温及4℃下储存长达90天的6毫升聚丙烯注射器中0.2毫克/毫升格隆溴铵注射液的稳定性。采用高效液相色谱稳定性指示分析法,在注射器制备后的0、1、4、7、15、30、45、60和90天测定格隆溴铵注射液的浓度水平。作为防腐剂添加的苯甲醇不干扰该分析。塑料注射器中的注射液在室温和4℃下均可稳定保存长达90天。在90天的研究期间,格隆溴铵注射液的pH值没有明显变化。这些数据表明在本研究中所考察的储存条件下格隆溴铵注射液具有稳定性。

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