Quality control of pharmaceuticals with NIR: From lab to process line

Sarraguça, Mafalda C.; Lopes, João A.

doi:10.1016/j.vibspec.2008.07.013

Cited by 77 publications

(42 citation statements)

References 23 publications

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“…Two commercial products with different content uniformity were considered and the two calibration sets included 7 samples in the range of 1-3% (w/w) and 12 samples in the range of 0.35-1.50% [18]. Creating calibration sets by under-overdosing samples can result in correlated concentrations between API and excipients [19]. Collinearity between concentrations leads to spurious predictions by attributing changes to the correlated formulation component instead of the real contributor [20].…”

Section: Different Levels Of the Investigated Propertymentioning

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: Different Levels Of the Investigated Propertymentioning

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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“…It was previously suggested that the optimum number of calibration samples would be around 40. For this reason, a calibration set with that number of samples was selected to these NIR calibrations [39]. Samples were prepared in amounts of 1.1g each.…”

Section: Laboratory Samplesmentioning

confidence: 99%

Simultaneous Determination of Clarithromycin, Tinidazole and Omeprazole in Helicure Tablets Using Reflectance Near-Infrared Spectroscopy with the Aid of Chemometry

Salam¹

2015

Pharm Anal Acta

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A near infrared spectroscopic method for the simultaneous determination of the active principles clarithromycin, tinidazole and omeprazole in a pharmaceutical preparation was developed. The three active principles are quantified using partial least-squares regression methods. The proposed method is applicable over a wide analyte concentration range (80-120%) of labeled content, so it requires careful selection of the calibration set and to ensure thorough homogenization of the product. The method was validated in accordance with the ICH standard validation guidelines for NIR spectroscopy by determining its selectivity, linearity, accuracy, precision and stability. Based on the results, it is an effective alternative to the existing choice (HPLC) for the same purpose.

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“…In respect to these uncertainties it is often considered prudent to undertake a pre-deployment scoping study first. In this scoping study the back propagation neural network classifier was selected to determine the predictive power of NIR instrumentation due to it being a general purpose classification tool which is able to model both linear and non-linear relationships [12].…”

Section: Introductionmentioning

confidence: 99%

Neural network classification of pharmaceutical active ingredient from near infrared spectra

Yee

Yan

2015

2015 2nd Asia-Pacific World Congress on Computer Science and Engineering (APWC on CSE)

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Abstract-This paper presents results from a scoping study undertaken with the intention of demonstrating the applicability of reflectance Near-Infrared (NIR) spectroscopy in classification of pharmaceutical type based on active ingredient. The part of the process selected for the scoping study is the packaging step in the manufacturing of pharmaceuticals. The rational for the selection of the packaging step is in older processing lines the product is classified after tablet coating and before blister packaging using visual automatic inspection techniques however for 100% conformance a more discriminating technique is required. In this study, NIR spectra (with wavelengths between 400nm and 1100nm) were obtained for samples pertaining to 3 different types of pharmaceuticals Quetiapine, Ibuprofen and Paracetamol. The dimensionality of the data set was reduced using Principal Components and the data was feed into a back propagation neural network configured to classify the data based on active ingredient type. The recognition rates achieved in this study were high enough to suggest that NIR spectroscopy is a viable method of ensuring 100% identification of pharmaceutical type prior to packaging for the pharmaceuticals tested.

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Quality control of pharmaceuticals with NIR: From lab to process line

Cited by 77 publications

References 23 publications

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

Simultaneous Determination of Clarithromycin, Tinidazole and Omeprazole in Helicure Tablets Using Reflectance Near-Infrared Spectroscopy with the Aid of Chemometry

Neural network classification of pharmaceutical active ingredient from near infrared spectra

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