
Standard Method Performance Requirements (SMPRs®) are a unique and novel concept for the analytical methods community. SMPRs are voluntary consensus standards, developed by stakeholders, that prescribe the minimum analytical performance requirements for classes of analytical methods.
Determine how much of a valuable, necessary, or characteristic ingredient is present in a product. Determine if a product meets specifications. Determine if a product meets regulatory requirements. Survey an environment to determine the presence and amount of a component, contaminant, or a nutrient. Identify a product and/or its components.
What: AOAC Standard Method Performance Requirements (SMPRs®) are voluntary consensus standards developed in accordance with the AOAC policy, “AOAC Due Process for Development of AOAC Non-Method Consensus Standards and Documents.” SMPRs describe a scientific community’s recommended minimum method performance characteristics and
Guidelines for Standard Method Performance Requirements - AOAC …
AOAC INTERNATIONAL brings together government, industry, and academia to establish standard methods of analysis that ensure the safety and integrity of foods and other products that impact public health around the world.
2020版《中国药典》分析方法验证指导原则中对准确度、精密度的 …
2019年7月24日 · 相对标准偏差(rsd):标准偏差与计算结果算术平均值的比值。 范围:系指分析方法能达到一定精密度、准确度和线性要求时的高低限浓度或量的区间。
Full text of "Appendix F Guidelines For Standard Method AOAC …
SMPRs are also voluntary standards. AOAC cannot, and does not, impose the use of SMPRs. Users are free to use SMPRs as they see fit. AOAC is very careful to include participants from as many regions of the world as possible so that SMPRs are accepted as international standards.
AOAC Method Validation (August 29, 2018) - Page 41
RSD i (Intermediate Precision) Background X An OMB Working Group created to consider the question of RSDi recommended the following: The RSDi of a method should not exceed 80% of the reproducibility standard deviation, or in AOAC’s case, no more than 80% the performance requirement specified for the relative standard deviation of ...
9101 分析方法验证指导原则 - 中国药典、药品标准、法规在线查询 …
分析方法验证(analytical method validation)的目的是证明建立的方法适合于相应检测要求。 在建立药品质量标准、变更药品生产工艺或制剂组分、修订原分析方法时,需对分析方法进行验证。 生物制品质量控制中釆用的方法包括理化分析方法和生物学测定方法,其中理化分析方法的验证原则与化学药品基本相同,所以可参照本指导原则进行,但在进行具体验证时还需要结合生物制品的特点考虑;相对于理化分析方法而言,生物学测定方法存在更多的影响因素,因此本指导原则 …
Intra-laboratory assessment of method accuracy ... - ScienceDirect
2010年10月15日 · Acceptable RSD values obtained from the Horwitz function and from the AOAC Peer Verified Methods program according to the concentration level of analyte (ppm = parts per millions, ppb = parts per billions).
AOAC SMPRs are used by AOAC expert review panels in their evaluation of validation study data for method being considered for Performance Tested Methods SM or AOAC Official Methods of
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