---
kind: "section"
citation: "21 C.F.R. § 74.1307"
title: "21"
number: "74.1307"
heading: "D&C Red No. 7."
url: "https://uscodex.org/cfr/21/74.1307"
---

# §74.1307. D&C Red No. 7.

- (a) **Identity.**
  - (1) **The color additive D&C Red No.** 7 is principally the calcium salt of 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-2-naphthalenecarboxylic acid (CAS Reg. No. 5281-04-9). To manufacture the additive, 2-amino-5-methylbenzenesulfonic acid is diazotized with hydrochloric acid and sodium nitrite. The diazo compound is coupled in alkaline medium with 3-hydroxy-2-naphthalenecarboxylic acid and the resulting dye converted to the calcium salt with calcium chloride.
  - (2) **Color additive mixtures for drug use made with D&C Red No.** 7 may contain only those diluents that are suitable and that are listed in [part 73](/cfr/21/part73.md) of this chapter as safe for use in color additive mixtures for coloring drugs.
- (b) **Specifications.** The color additive D&C Red No. 7 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by current good manufacturing practice:
- (c) **Uses and restrictions.** The color additive D&C Red No. 7 may be safely used for coloring drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of the drug.
- (d) **Labeling.** The label 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) **Certification.** All batches of D&C Red No. 7 shall be certified in accordance with regulations in [part 80](/cfr/21/part80.md) of this chapter.

## Notes

### Amendments

[47 FR 57687, Dec. 28, 1982, as amended at 77 FR 39923, July 6, 2012]

### Authority

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

### Source

Source: 42 FR 15654, Mar. 22, 1977, unless otherwise noted.

### Amendments

[47 FR 57687, Dec. 28, 1982, as amended at 77 FR 39923, July 6, 2012]