采用高效液相色谱-质谱联用技术和效价测定法对美国市场注射用万古霉素产品进行质量评估。
Quality assessment of U.S. marketplace vancomycin for injection products using high-resolution liquid chromatography-mass spectrometry and potency assays.
机构信息
Division of Pharmaceutical Analysis, CDER, Food and Drug Administration, St Louis, Missouri, USA.
出版信息
Antimicrob Agents Chemother. 2012 Jun;56(6):2824-30. doi: 10.1128/AAC.00164-12. Epub 2012 Feb 27.
Abstract
In response to a published concern about the potency and quality of generic vancomycin products, the United States Food and Drug Administration investigated a small sampling of the vancomycin products available in North America with regard to purity, content, and potency. To facilitate identification of impurities, a new liquid chromatography method was developed using high-resolution mass spectrometry in addition to diode array detection to characterize impurities in several commercial products. Furthermore, a microbiological assay was utilized to link the analytical profiles with an in vitro potency. All products tested met the quality specifications outlined in the United States Pharmacopeia (USP) (vancomycin hydrochloride for injection monograph) for impurities and potency (USP, Vancomycin hydrochloride for injection. United States Pharmacopeia and National Formulary, vol USP 34-NF 29, 2011).
摘要
针对人们对普通万古霉素产品的效力和质量的担忧，美国食品药品监督管理局对北美市场上的万古霉素产品进行了小规模抽样调查，检查其纯度、含量和效力。为了便于鉴定杂质，采用了一种新的液相色谱法，结合高分辨率质谱和二极管阵列检测，对几种商业产品中的杂质进行了特征分析。此外，还采用微生物学检测方法，将分析结果与体外效力联系起来。所有测试产品均符合美国药典（USP）（注射用盐酸万古霉素专论）中规定的杂质和效力标准（USP，注射用盐酸万古霉素。美国药典和国家处方集，第 34 卷-NF 29，2011 年）。
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