---
kind: "section"
citation: "21 C.F.R. § 73.1400"
title: "21"
number: "73.1400"
heading: "Pyrophyllite."
url: "https://uscodex.org/cfr/21/73.1400"
---

# §73.1400. Pyrophyllite.

- (a) **Identity.**
  - (1) The color additive pyrophyllite is a naturally occurring mineral substance consisting predominantly of a hydrous aluminum silicate, Al2O3·4SiO2·H2 O, intimately mixed with lesser amounts of finely divided silica, SiO2. Small amounts, usually less than 3 percent, of other silicates, such as potassium aluminum silicate, may be present. Pyrophyllite may be identified and semiquantitatively determined by its characteristic X-ray powder diffraction pattern and by its optical properties.
  - (2) Color additive mixtures made with pyrophyllite are limited to those listed in this subpart as safe and suitable in color additive mixtures for coloring externally applied drugs.
- (b) **Specifications.** Pyrophyllite shall conform to the following specifications:
- (c) **Uses and restrictions.** Pyrophyllite may be safely used in amounts consistent with good manufacturing practice to color drugs that are to be externally applied.
- (d) **Labeling requirements.** The labeling of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of [§ 70.25](/cfr/21/70.25.md) of this chapter.
- (e) **Exemption from certification.** Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of [section 721(c)](/cfr/21/721.md?p=c) of the act.

## Notes

### Authority

Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.

### Source

Source: 42 FR 15643, Mar. 22, 1977, unless otherwise noted.