The amount of pearlescent pigment added in the drug

Addition amount of pearlescent pigment in medicine

21 CFR § 73.1350-Mica Pearlescent Pigment

(a) Material composition

(1) The color additives are formed by depositing titanium and/or iron salts on mica and then heating to produce one of the following combinations: titanium dioxide on mica; mica oxide on iron; titanium dioxide and iron oxide on mica. The mica used in the manufacture of color additives shall meet the requirements of § 73.1496(a)(1).

(2) For medicines made with mica pearlescent pigments, with color additive mixtures, the diluents of the color additive mixtures that are safe and suitable for coloring the ingested medicine can be listed.

(b) Specifications. Mica pearlescent pigments should meet the following standards and should be free of impurities other than the specified impurities in order to avoid such other impurities through good manufacturing practices:

(1) Lead (calculated as Pb), no more than four parts per million (ppm).

(2) Arsenic (calculated as As), no more than 3 ppm.

(3) Mercury (in Hg), not more than 1 ppm.

(c) Uses and restrictions. Mica pearlescent pigments can be safely used to color ingested medicines up to 3% of the final drug product. The maximum amount of iron used in the production of the pigment does not exceed 55% by weight in the finished pigment.

(d) Label. The labeling of color additives and any mixtures prepared from them for coloring, alone or in part, shall comply with the requirements of the Federal Food, Drug, and Cosmetic Act.

(e) Exemption from certification. The certification of this color additive is not necessary to protect public health, so its batch is not subject to the certification requirements of Article 721(c) of the Federal Food, Drug, and Cosmetic Act.