Effects and Detection of Raw Material Variability on the Performance of Near-Infrared Calibration Models for Pharmaceutical Products

Igne, Benoît; Shi, Zhenqi; Drennen, James K.; Anderson, Carl A.

doi:10.1002/jps.23816

Cited by 21 publications

(19 citation statements)

References 33 publications

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“…Only changes in the particle size of lactose produced biased predictions in both ambient and chamber conditions. The authors tested variableselection methods to increase method robustness to raw material variability [32].…”

Section: Design Of Experiments Strategymentioning

confidence: 99%

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

Tomuță¹,

Porfire²,

Casian³

et al. 2018

Calibration and Validation of Analytical Methods - A Sampling of Current Approaches

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Vibrational spectroscopy, namely near infrared (NIR) and Raman spectroscopy, is based on the interaction between the electromagnetic radiation and matter. The technique is sensitive to chemical and physical properties and delivers a wide range of information about the analyzed sample, but in order to extract the information, multivariate calibration of the spectral data is required. The main goal of this work will be to present in detail the available multivariate calibration strategy for development of NIR and Raman spectroscopic methods, which was successfully applied in pharmaceutics.

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Section: Design Of Experiments Strategymentioning

confidence: 99%

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

Tomuță¹,

Porfire²,

Casian³

et al. 2018

Calibration and Validation of Analytical Methods - A Sampling of Current Approaches

View full text Add to dashboard Cite

show abstract

“…A similar evaluation of the sensitivity of NIR spectroscopy was studied through the effect of raw material variability in the manufacturing of tablets. 3 Using a four-component formulation varied using a quaternary mixture design, test samples were produced at the model centre by changing the properties of the raw materials. A total of 12 test design points, all at the same concentration level, but with different raw material properties were manufactured.…”

Section: Raw Materials Variabilitymentioning

confidence: 99%

EAS Award Lecture: When the Sample Makes (or Breaks) the Technology

Igne

2016

NIR news

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“…), environmental effects (changes in relative humidity in storage facilities), and active ingredient(s) and excipients variability are likely to affect the analytical abilities of a technique. Igne et al studied the effects of instrumental aging, excipient particle size distribution, excipient manufacturer variability, and active ingredient physical transformation. The study concluded that variation in the raw material properties had a significant impact on the precision and the accuracy of predictions from the model.…”

Section: Excipient Variability Analysismentioning

confidence: 99%