Methods that determine the relative purity of biopharmaceuticals represent the most widely used form of analysis for the pharmaceutical industry. The ability to rapidly assess method capability or the uncertainty of measurements under actual use conditions continues to present significant challenges. We have refined and applied the model of Uncertainty Based on Current Information to predict the precision of the purity measurements and compared the predicted precision to the measured variability for several different types of purity methods. The measured method variability was derived from the analysis of data sets ranging from hundreds to thousands of measurements for each different method type. The predicted precision was found to be in excellent agreement with the statistically obtained values with R = 0.94. This demonstration of concurrence between the predicted and actual precision provides an opportunity for streamlining laborious conventional (statically derived) assessment of method precision and leveraging the Uncertainty Based on Current Information model utilizing much smaller data sets or even a single experiment.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.xphs.2020.01.013 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
AQbD integrated High-Performance Thin Layer Chromatographic Method for Quantitative Estimation of Tavaborole in the presence of its degradants and the matrix of nanostructured lipid carriers.
Drug Dev Ind Pharm
January 2025
Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology (CHARUSAT), Changa - 388421, Anand, Gujarat, India.
Background: Tavaborole (TAV), a benzoxaborole derivative, is an FDA-approved antifungal agent for treating onychomycosis, a common and persistent fungal infection of the toenails.
Objective: This study aimed to develop a robust stability-indicating HPTLC method to determine TAV in nanostructured lipid carriers (NLC) using a comprehensive approach that includes risk assessment, and Analytical Quality by Design.
Methods: The critical method parameters influencing the HPTLC results were screened using a Placket-Burman screening design followed by its optimization using a central composite optimization design.
The spatially informed mFISHseq assay resolves biomarker discordance and predicts treatment response in breast cancer.
Nat Commun
January 2025
MultiplexDX, s.r.o., Comenius University Science Park, Bratislava, Slovakia.
Current assays fail to address breast cancer's complex biology and accurately predict treatment response. On a retrospective cohort of 1082 female breast tissues, we develop and validate mFISHseq, which integrates multiplexed RNA fluorescent in situ hybridization with RNA-sequencing, guided by laser capture microdissection. This technique ensures tumor purity, unbiased whole transcriptome profiling, and explicitly quantifies intratumoral heterogeneity.
View Article and Find Full Text PDFRényi relative entropy based monogamy of entanglement in tripartite systems.
Sci Rep
January 2025
Department of Computer Science and Engineering, New York University Shanghai, 567 West Yangsi Road, Pudong, Shanghai, 200124, China.
A comprehensive investigation of the entanglement characteristics is carried out on tripartite spin-1/2 systems, examining prototypical tripartite states, the thermal Heisenberg model, and the transverse field Ising model. The entanglement is computed using the Rényi relative entropy. In the traditional Rényi relative entropy, the generalization parameter α can take values only in the range [Formula: see text] due to the requirements of joint convexity of the measure.
View Article and Find Full Text PDFHigh-purity hydrogen production from dehydrogenation of methylcyclohexane catalyzed by zeolite-encapsulated subnanometer platinum-iron clusters.
Nat Commun
January 2025
Engineering Research Center of Advanced Rare-Earth Materials of Ministry of Education, Department of Chemistry, Tsinghua University, Beijing, China.
Liquid organic hydrogen carriers (LOHCs) are considered promising carriers for large-scale H storage and transportation, among which the toluene-methylcyclohexane cycle has attracted great attention from industry and academia because of the low cost and its compatibility with the current infrastructure facility for the transportation of chemicals. The large-scale deployment of the H storage/transportation plants based on the toluene-methylcyclohexane cycle relies on the use of high-performance catalysts, especially for the H release process through the dehydrogenation of methylcyclohexane. In this work, we have developed a highly efficient catalyst for MCH dehydrogenation reaction by incorporating subnanometer PtFe clusters with precisely controlled composition and location within a rigid zeolite matrix.
View Article and Find Full Text PDFNanomorphogenesis of interlayered polyamide membranes for precise ion sieving in lithium extraction.
Water Res
December 2024
Research Center for Membrane and Film Technology, Kobe University, 1-1 Rokkodaicho, Nada, Kobe 657-8501, Japan; Department of Chemical Science and Engineering, Kobe University, 1-1 Rokkodaicho, Nada, Kobe 657-8501, Japan. Electronic address:
Nanofiltration (NF) offers a scalable and energy-efficient method for lithium extraction from salt lakes. However, the selective separation of lithium from magnesium, particularly in brines with high magnesium concentrations, remains a significant challenge due to the close similarity in their hydrated ionic radii. The limited Li/Mgselectivity of current NF membranes is primarily attributed to insufficient control over pore size and surface charge.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!