Identification and Local Chemical Analysis of Pharmaceutical Impurities
نویسندگان
چکیده
منابع مشابه
Elemental Impurities in Pharmaceutical Excipients.
Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products. Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled in part by ...
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While the use of pharmaceuticals is always a balance of risks and benefits, the same is not true for impurities in pharmaceuticals; impurities convey only risk. A number of international guidelines and regional guidances instruct drug developers and regulatory agencies on how to evaluate and control impurities in drug substances and drug products. While impurities should always be reduced to th...
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ژورنال
عنوان ژورنال: Microscopy and Microanalysis
سال: 2011
ISSN: 1431-9276,1435-8115
DOI: 10.1017/s1431927611006532