Bracketed Stability Evaluation of Methimazole USP in PLO Gel Mediflo™30 Pre-Mixed.

Q4 Medicine International journal of pharmaceutical compounding Pub Date : 2024-05-01
Anh Tran, Kathryn Hunt, Claude Bernal, Erica Cull
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引用次数: 0

Abstract

Extemporaneously compounded Methimazole 1% and 10% in PLO Gel Mediflo™30 Pre-Mixed were studied to assess physical, chemical and microbial stability over time. The formulations were stored at room temperature in tightly closed, light resistant plastic containers. Chemical stability was evaluated using a validated, stability indicating HPLC analysis and physical stability was evaluated through observation of organoleptic appearance and pH measurement at predetermined time points. Lastly, antimicrobial effectiveness testing was conducted per USP <51> guidelines. The results indicate that compounded Methimazole remained within the stability criteria for the duration of the study and can be assigned an extended beyond-use-date of 120 days under the studied conditions.

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预混 PLO 凝胶 Mediflo™30 中的甲巯咪唑 USP 的括号稳定性评估。
研究了在 PLO Gel Mediflo™30 预混剂中临时复配的 1%和 10%甲巯咪唑,以评估其在一段时间内的物理、化学和微生物稳定性。制剂在室温下储存于密闭、避光的塑料容器中。化学稳定性采用经过验证的稳定性指示 HPLC 分析法进行评估,物理稳定性则通过观察感官外观和在预定时间点测量 pH 值进行评估。最后,根据美国药典指南进行了抗菌效果测试。结果表明,在研究期间,复方甲巯咪唑仍符合稳定性标准,在研究条件下,可延长 120 天的使用期限。
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来源期刊
CiteScore
0.40
自引率
0.00%
发文量
62
期刊介绍: The International Journal of Pharmaceutical Compounding (IJPC) is a bi-monthly, scientific and professional journal emphasizing quality pharmaceutical compounding. IJPC is the only publication that covers pharmaceutical compounding topics relevant and necessary to empower pharmacists to meet the needs of today"s patients. No other publication features hands-on, how-to compounding techniques or the information that contemporary pharmacists need to provide individualized care.
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