scholarly journals A Practical Way to ISO/GUM Measurement Uncertainty for Analytical Assays Including In-House Validation Data

2018 ◽  
Author(s):  
Antonio Gustavo González ◽  
María Ángeles Herrador ◽  
Agustín García Asuero ◽  
Julia Martín
Keyword(s):  
Measurement Uncertainty ◽  
Validation Data ◽  
Iso Gum

Measurement uncertainty evaluation from correlated validation data: Determination of elemental impurities in pharmaceutical products by ICP-MS

Talanta ◽  
2020 ◽  
Vol 220 ◽  
pp. 121386 ◽  
Author(s):  
David Milde ◽  
Tomáš Pluháček ◽  
Martin Kuba ◽  
Jitka Součková ◽  
Ricardo J.N. Bettencourt da Silva
Keyword(s):  
Measurement Uncertainty ◽  
Pharmaceutical Products ◽  
Uncertainty Evaluation ◽  
Validation Data ◽  
Elemental Impurities ◽  
Icp Ms ◽  
Measurement Uncertainty Evaluation

scholarly journals Evaluation of Standard Measurement Uncertainty From Method Validation Data for the ICP-OES Determination of Nb, Ta, Fe, Mn, Ti, Sn, Zr, and W in Niobite-Tantalite Samples

2019 ◽  
Vol 40 (5) ◽  
pp. 179-187
Author(s):  
V. Padmasubashini ◽  
V.V. Hanuman ◽  
S.B. Singh ◽  
S. Hamilton ◽  
M.B. Verma
Keyword(s):  
Measurement Uncertainty ◽  
Method Validation ◽  
Icp Oes ◽  
Validation Data ◽  
Standard Measurement

Determination of Vitamin B12 in Infant Formula and Adult Nutritionals Using HPLC After Purification on an Immunoaffinity Column: First Action 2011.09

2012 ◽  
Vol 95 (4) ◽  
pp. 933-936 ◽  
Author(s):  
Ursula Kirchner ◽  
Katharina Degenhardt ◽  
Guenther Raffler ◽  
Maria Nelson
Keyword(s):  
Vitamin B12 ◽  
Measurement Uncertainty ◽  
Infant Formula ◽  
Potassium Cyanide ◽  
Immunoaffinity Column ◽  
Validation Data ◽  
Method Performance ◽  
Expert Review ◽  
Wide Range

Abstract During the “Standards Development and International Harmonization: AOAC INTERNATIONAL Mid-Year Meeting,” on June 29, 2011, the method “Determination of Vitamin B12 in Infant Formula and Adult Nutritionals Using HPLC After Purification on an Immunoaffinity Column” was recommended by an Expert Review Panel and adopted as AOAC Official First Action status. The method is applicable for the determination of vitamin B12 in milk-based infant formula. Vitamin B12 is extracted from the sample in sodium acetate buffer in the presence of potassium cyanide. After purification and concentration with an immunoaffinity column (IAC), vitamin B12 is determined by LC with UV detection (361 nm). Data supplied by CLF demonstrated linear response over a wide range of concentrations (1.4–39 μg/100 mL). The analytical range is 0.2–10 μg/100 g, depending on the capacity of the IACs (0.01–0.5 μg), the input weight, and dilutions. Recovery rates were assessed using National Institute of Standards and Technology SRM 1849, and determined to be 95.1%, with SD of 0.34 and CV of 9.0. Measurement uncertainty (UE) was 0.8 μg/100 g, which was calculated from the validation data. It is an expanded measurement uncertainty and was obtained through multiplication with a coverage factor k. LOQ values were reported as 0.10 μg/100 g. The performance characteristics of the method met the standard method performance requirements set forth by the AOAC Stakeholder Panel on Infant Formula and Adult Nutritionals; thus, the method was determined to be appropriate for First Action status.

scholarly journals Evaluating Measurement Uncertainty in the Microbiological Assay of Vancomycin from Methodology Validation Data

2007 ◽  
Vol 90 (5) ◽  
pp. 1383-1386 ◽  
Author(s):  
Felipe Rebello Lourenço ◽  
Telma Mary Kaneko ◽  
Terezinha De Jesus Andreoli Pinto
Keyword(s):  
Measurement Uncertainty ◽  
Uncertainty Estimation ◽  
Antibiotic Activity ◽  
Microbiological Assay ◽  
Base Layer ◽  
Expanded Uncertainty ◽  
Validation Data ◽  
Standard Curve ◽  
Microbiological Methods ◽  
Measurement Uncertainty Estimation

Abstract Methodology validation and measurement uncertainty estimation are fundamental to obtain reliable results. The microbiological methods are widely used to determine antibiotic assay, as they permit evaluation of the analyzed antibiotic activity. A microbiological assay of vancomycin was performed with adoption of experimental design 5 1 (interpolation in 5-point standard curve assay) with final concentrations from 6.4 to 15.6 g/mL (standards) and 10.0 g/mL (sample). Bacillus subtitlis (ATCC 6633) was the microorganism used, with antibiotic medium No. 8 as base layer and inoculated layer. The plates were incubated at 37C for 18 h. The method adopted for the microbiological assay of vancomycin through agar diffusion was validated according to statistic results demonstrated for suitability of the method concerning linearity, precision, and accuracy. The estimated relative expanded uncertainty (4.3) was considered adequate for this method purpose.

Determination of measurement uncertainty for the determination of triazines in groundwater from validation data

The Analyst ◽  
2001 ◽  
Vol 126 (2) ◽  
pp. 211-216 ◽  
Author(s):  
Thomas P. J. Linsinger ◽  
Manuela Führer ◽  
Wolfgang Kandler ◽  
Rainer Schuhmacher
Keyword(s):  
Measurement Uncertainty ◽  
Validation Data

Comparison of ISO-GUM and Monte Carlo methods for the evaluation of measurement uncertainty: Application to direct cadmium measurement in water by GFAAS

Talanta ◽  
2011 ◽  
Vol 83 (5) ◽  
pp. 1568-1574 ◽  
Author(s):  
Dimitrios Theodorou ◽  
Loukia Meligotsidou ◽  
Sotirios Karavoltsos ◽  
Apostolos Burnetas ◽  
Manos Dassenakis ◽  
...  
Keyword(s):  
Monte Carlo ◽  
Measurement Uncertainty ◽  
Monte Carlo Methods ◽  
Iso Gum

Comparison of ISO-GUM and Monte Carlo Method for Evaluation of Measurement Uncertainty

2014 ◽  
Vol 38 (7) ◽  
pp. 647-656
Author(s):  
Young-Cheol Ha ◽  
Jae-Young Her ◽  
Seung-Jun Lee ◽  
Kang-Jin Lee
Keyword(s):  
Monte Carlo ◽  
Monte Carlo Method ◽  
Measurement Uncertainty ◽  
Iso Gum

Assessment of the UVB Transmittance Measurement Uncertainty in Conformity with ISO/IEC 17025

2013 ◽  
Vol 479-480 ◽  
pp. 149-154
Author(s):  
Jen Yu Shieh ◽  
Song Yuh Huang ◽  
Song Chi Huang ◽  
Kun Hsien Lin ◽  
Wei Cheng Huang
Keyword(s):  
Quality Assurance ◽  
Measurement Uncertainty ◽  
Test System ◽  
Stable Operation ◽  
Laboratory System ◽  
System Construction ◽  
Measurement Quality ◽  
Uncertainty In Measurement ◽  
Iso Gum ◽  
Expression Of Uncertainty

The main purpose of this research is to construct a laboratory for testing standard. It refers to the spirit of ISO/IEC 17025 Standard, and follows Guide to the Expression of Uncertainty in Measurement (ISO GUM) made by ISO organization. The content includes UV test system construction, UVB transmittance measurement uncertainty, and the plan of measurement quality assurance that assures the stable operation of the laboratory system. Construct the equations of measurement uncertainty by the system methods that apply to the UVB transmittance measurement of car insulation film, and evaluate the variance with transmittance measurement measured by UV spectroradiometer. As for the results of transmittance measurement, the transmittance is between 0.87214 and 1.02146(%) with single wavelength of 294.5nm. There is little difference between the manufacturer label value and the measured one. The verification proofs the effectiveness of the system, and allows the tests of commercial UV-cut products fit the international and world standards.

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