Challenges and risks associated with impurity profiles in technical grade crop protection products produced semi-synthetically from natural products

Peter Maienfisch
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引用次数: 1

Abstract

The safety of crop protection products and their safe use is of paramount importance and requires that crop protection products are consistently marketed and used worldwide in the required registered quality. To meet these high-quality requirements, the highest demands must be placed on the production and purification of technical-grade crop protection products. In this context, impurity profiles are of utmost importance, as unknown impurities at higher than registered concentrations may pose new unknown toxicological risks to users, consumers, and the environment. Particularly high demands are placed on the production and purification of technical grade semisynthetic derivatives of fermentatively derived natural products to meet the required regulatory specifications, to ensure that relevant impurities do not exceed maximum allowable concentrations, to ensure the safe use of such products, and to eliminate any unknown product safety risks. The challenges associated with the manufacture and purification of Afidopyropen and the product safety risks associated with various qualities of technical grade Emamectin benzoate are discussed in detail.

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在由天然产品半合成生产的技术级作物保护产品中与杂质相关的挑战和风险
作物保护产品的安全性及其安全使用至关重要,并要求作物保护产品在全球范围内以所需的注册质量持续销售和使用。为了满足这些高质量的要求,必须对技术级作物保护产品的生产和纯化提出最高的要求。在这种情况下,杂质概况是至关重要的,因为高于注册浓度的未知杂质可能会对用户、消费者和环境造成新的未知毒理学风险。对发酵衍生天然产品的技术级半合成衍生物的生产和纯化提出了特别高的要求,以满足所需的监管规范,确保相关杂质不超过最大允许浓度,确保此类产品的安全使用,并消除任何未知的产品安全风险。详细讨论了与阿维菌素的生产和纯化相关的挑战以及与不同质量的技术级苯甲酸埃马菌素相关的产品安全风险。
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