International Journal of Pharmaceutical Compounding

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Selection of Color Additives: A Regulatory View

Author(s): Kumar Anuj, Dureja Harish, Madan Anil K

Issue: Jul/Aug 2012 - Volume 16, Number 4
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Page(s): 304-309

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Abstract: Color additives have a unique place in the categories of the excipients. However, most of the color additives are complex heterogeneous organic compounds. In pharmaceuticals, colors are used in various oral (solid, liquid) and topical dosage form. Different regulatory authorities have their own specific set of regulation for registration, approval, and control of color additives. However, at this time of globalization, selection of appropriate color is not an easy task when a company wants to sale its product in many countries. In this article, the authors have explored various important factors which should be considered in the selection of color additives.

Related Keywords: Anuj Kumar, M Pharm, Harish Dureja, M Pharm, PhD, Anil K. Madan, PhD, color additives, dyes, colorants, drug safety, regulation, U.S. Food and Drug Administration, FDA, pigments, psychological effects, compatibility, stability

Related Categories: EXCIPIENTS, LEGAL

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