Color measurement of a solid active pharmaceutical ingredient as an aid to identifying key process parameters

Oram, Paul; Strine, Jeffrey

doi:10.1016/j.jpba.2005.08.006

Cited by 13 publications

(14 citation statements)

References 6 publications

(6 reference statements)

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“…They are used in assembly lines to identify and classify products by color. The objectives of their usage include to check the quality of products [3][4][5], to facilitate sorting and packaging [6][7][8], to assess the equality of products in storage [9,10], and to monitor waste products [11]. Consequently, there is abundant of color sensors and the choice is often application-driven [8,16].…”

Section: Introductionmentioning

confidence: 99%

Optoelectronic Sensor Solid Surface Color Analyzer

Telman¹,

Bakhtiyor²,

Nasrulla³

2018

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In the paper, studies of fiber transmission lines have been considered, for measurements of distances in space and atmosphere, the study of atoms and molecules and in solving other problems of science and technology. The article deals with one of the pulse methods of fiber optics, i.e. scatterometry or backscattering for metal surfaces qualitative parameters control. This object can be apply not only to radio electronics, but also to physics, chemistry, biology and other areas of science and technology.

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Section: Introductionmentioning

confidence: 99%

Optoelectronic Sensor Solid Surface Color Analyzer

Telman¹,

Bakhtiyor²,

Nasrulla³

2018

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“…They are used in assembly lines to identify and classify products by color. The objectives of their usage include to check the quality of products [1][2][3], to facilitate sorting and packaging [4][5][6], to assess the equality of products in storage [7,8], and to monitor waste products [9]. Consequently, there is abundant of color sensors and the choice is often application-driven [22,23].…”

Section: Introductionmentioning

confidence: 99%

Design And Characterization Of Automated Color Sensor System

Assaad

Yohannes

Bermak

et al. 2014

International Journal on Smart Sensing and Intelligent Systems

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The paper presents a color sensor system that can process light reflected from a surface and produce a digital output representing the color of the surface. The end-user interface circuit requires only a 3-bit pseudo flash analog-to-digital converter (ADC) in place of the conventional/typical design comprising ADC, digital signal processor and memory. For scalability and compactness, the ADC was designed such that only two comparators were required regardless of the number of color/wavelength to be identified. The complete system design has been implemented in hardware (bread board) and fully characterized. The ADC achieved less than 0.1 LSB for both INL and DNL. The experimental results also demonstrate that the color sensor system is working as intended at 20 kHz while maintaining greater than 2.5 ENOB by the ADC. This work proved the design concept and the system will be realized with integrated circuit technology in future to improve its operating frequency.

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“…The use of these color spaces allows the spectroscopic result to be conveniently reduced to three numbers, a format that is particularly amenable to the setting of a color specification, albeit with the loss of some information. Although color measurements have been reported using either transmittance or absorbance values at selected wavelengths or using a summation of the total absorbance of the spectrum [10,11], the use of single or multiple transmittance or reflectance values can be problematic because the color of the material may be misrepresented. This is particularly critical in pharmaceutical APIs and starting materials where color may be introduced from multiple sources that are not fully understood even in commercial processes.…”

Section: Introductionmentioning

confidence: 99%

A Systematic Method Development Strategy for Quantitative Color Measurement in Drug Substances, Starting Materials, and Synthetic Intermediates

et al. 2011

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The color of active pharmaceutical ingredients (APIs) can be a critical quality attribute for pharmaceutical products. Color variation can be indicative of contaminants, chemical impurities, solid-state form impurities, or degradation products. The color of the pharmaceutical materials is typically specified and determined using visual appearance testing. To avoid the inherent subjectivity of visual appearance testing, to understand the link between the color and the process parameters, and to facilitate quality agreements between customers and vendors of chemical starting materials, quantitative color measurements utilizing visible spectroscopic methods are increasingly needed. In this work, a systematic method development strategy (MDS) is described to assist with the development of robust and rugged quantitative color measurement methods based on a science-and risk-based approach aligned with quality-bydesign principles. The MDS is illustrated using typical scenarios encountered in method development through several examples including a method developed for 2,3-dimethyl-2H-indazol-6-amine, a starting material in the commercial synthesis of pazopanib hydrochloride API.Flowcharts and examples are presented to illuminate key decision points in the MDS process including selection of (1) solution-state versus solid-state spectroscopic method, (2) optimal color space for reporting color measurement results, and (3) appropriate method risk assessment and control to ensure successful method implementation.General guidance is also provided to facilitate the discussion for setting quantitative color specifications.

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Color measurement of a solid active pharmaceutical ingredient as an aid to identifying key process parameters

Cited by 13 publications

References 6 publications

Optoelectronic Sensor Solid Surface Color Analyzer

Optoelectronic Sensor Solid Surface Color Analyzer

Design And Characterization Of Automated Color Sensor System

A Systematic Method Development Strategy for Quantitative Color Measurement in Drug Substances, Starting Materials, and Synthetic Intermediates

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