Quality Control: Water Activity Considerations for Beyond-use Dates.

Q4 Medicine International journal of pharmaceutical compounding Pub Date : 2024-09-01
Loyd V Allen
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Abstract

There are minimum levels of water activity that are required for growth of bacteria and molds. Water activity is the ratio of vapor pressure of water in a product to pure water at the same temperature. Pure distilled water has a water activity of 1. Water activity is also a measure of water in a material that is available to react with or attach itself to other material; it is also called "free" water while the unavailable water is called "bound" water. Higher water activity substances tend to support more microorganisms; bacteria usually require water activity values of at least 0.91 and fungi at least 0.6. Every microorganism has a limit of water activity below which it will not grow. To lower water activity, one can add or change the concentrations of ingredients such as sodium chloride, sucrose, alcohol, propylene glycol, or glycerin so the preparation becomes self-preserving. Also, if the preparation has too high a water activity and the addition of other substances to lower the water activity, then a preservative may be required for the preparation. Nonaqueous liquids or dry solids will not support spore germination or microbial growth due to their low water activity.

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质量控制:使用后日期的水活性考虑因素。
细菌和霉菌的生长需要最低限度的水活性。水活度是产品中水的蒸气压与相同温度下纯水的比值。纯蒸馏水的水活度为 1。水活度也是一种衡量物质中可与其他物质发生反应或附着在其他物质上的水的指标,也称为 "自由 "水,而不可用的水称为 "结合 "水。水活度越高的物质往往支持更多的微生物;细菌通常要求水活度值至少为 0.91,真菌至少为 0.6。每种微生物都有一个水活度极限,低于这个极限就不会生长。要降低水活性,可以添加或改变氯化钠、蔗糖、酒精、丙二醇或甘油等成分的浓度,使制剂具有自我保存性。此外,如果制剂的水活度过高,而添加其他物质又无法降低水活度,则可能需要为制剂添加防腐剂。非水性液体或干固体由于水活性低,不会支持孢子发芽或微生物生长。
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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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