Selection of color additives: a regulatory view.
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.
Drug Regulatory Affairs, Department of Pharmaceutical Sciences, JCDM College of Pharmacy, Sirsa, Haryana, India. anuj_teotia81@rediffmail.com
Anuj
A
Kumar
Harish
H
Dureja
Anil K
AK
Madan
D004396:Coloring Agents / Q000009:adverse effects; D004340:Drug Contamination; D004335:Drug and Narcotic Control
D004396:Coloring Agents