化妆品稳定性研究的参数

从远古时代开始，化妆品就一直在使用，但是最近过去，由于意识提高，人们对个人医疗保健和美容产品的需求激增。传统上，美国和欧盟是领先的市场，但其他发展中经济体也为这种产品的市场增长做出了贡献。全球的监管机构提出了严格的要求，以确保化妆品的安全使用，此类要求还包括稳定性研究，这些研究可以保证产品在保质期间保留其宣告的功能。

Stability Test Parameters

化妆品的稳定性研究旨在确保产品或修改版本符合预期的物理，化学和微生物质量标准，以及在规定条件下存储时功能和美学。从总体上讲，此类测试属于三类：

身体的：chemical: appearance, colour, odour/fragrance, viscosity, texture, flow and emulsion stability, density, refractive index, light stability, etc. Accelerated stability testing is used to arrive at the expiry date of the product.

微生物学：细菌，霉菌和酵母的生长污染。

包装兼容性：包装和产品的完整性在预期的存储和运输条件下。

Cosmetic and personal healthcare products fall in several usage categories and sub-categories.It is not possible to elaborate upon details of stability testing on all the categories and in this brief article an attempt is made to outline some of the general test parameters.

Physical/Chemical Tests

Light exposure often leads to discolouration of the product or the package/label.
离心机测试用于测试乳液的稳定性。乳液层或油滴的分离称为奶油。将乳液加热至50°C，并在3000 rpm处离心30分钟。
Temperature cycling at elevated temperature provides accelerated stability testing. Some tests are conducted at 45°C or 37°C for three months. Routine room temperature studies (25°C) are required to be conducted for two years. Freeze – thaw cycling reveals detail on product stability. It is done at 0°C or -10°C. Product is kept at -10°C for 24 hours and at 25°C for next 24 hours (referred to as cycle). A product passing these cycles tests is considered stable. If the temperature is cycled between -10°C and 45°C for three 24 hour cycles it is considered to be a high-quality product.
进行机械冲击测试以确定运输运动是否会损坏产品或其包装。在此类测试的不同阶段，可以对颜色，香气，粘度，pH值，粒度等进行测量。

包装

包装可防止产品与环境的相互作用。它可以通过空气或暴露于水蒸气来保护产品免受氧化的影响。同时，它通过蒸发挥发性成分来防止散发香料的流失。包装的测试包括泄漏测试，减肥测试和惰性容器中的测试。

Microbiological Stability Tests

Microbiological contamination can result during manufacture, transportation or during usage by consumer. It can result in deterioration of quality of the product. Screening tests using rapid semi qualitative or quantitative tests involving enrichment culturing and colony counting are often employed.

In a subsequent article stability chambers will be covered which are used for conducting stability studies on a range of products covering pharmaceuticals, foods and cosmetics.

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