---
kind: "section"
citation: "21 C.F.R. § 640.101"
title: "21"
number: "640.101"
heading: "General requirements."
url: "https://uscodex.org/cfr/21/640.101"
---

# §640.101. General requirements.

- (a) **Heat stability test.** Approximately 2 ml. of completely processed material of each lot shall not show any visible sign of gelation after heating in a 12 × 75 mm. stoppered glass tube at 57 °C for 4 hours.
- (b) **pH.** The pH of final container material shall be 6.8 ±0.4 when measured in a solution diluted to 1 percent protein with 0.15 molar sodium chloride.
- (c) **Turbidity.** The product shall be free of turbidity as determined by visual inspection of final containers.
- (d) **Date of manufacture.** The date of manufacture is the date of initiating the last valid measles or poliomyelitis antibody test ([§ 640.104(b)](/cfr/21/640.104.md?p=b) (2) and (3)) whichever date is earlier.
- (e) **Labeling.** In addition to complying with all applicable labeling required in this subchapter, labeling shall indicate that:
  - (1) **There is no prescribed potency for viral hepatitis antibodies.**
  - (2) **The product is not recommended for intravenous administration.**

## Notes

### Amendments

[38 FR 32089, Nov. 20, 1973; 48 FR 13026, Mar. 29, 1983, as amended at 49 FR 23834, June 8, 1984; 50 FR 4140, Jan. 29, 1985; 51 FR 15611, Apr. 25, 1986; 55 FR 11013, Mar. 26, 1990; 63 FR 16685, Apr. 6, 1998; 64 FR 26287, May 14, 1999]

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.

### Source

Source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted.

### Amendments

[38 FR 32089, Nov. 20, 1973; 48 FR 13026, Mar. 29, 1983, as amended at 49 FR 23834, June 8, 1984; 50 FR 4140, Jan. 29, 1985; 51 FR 15611, Apr. 25, 1986; 55 FR 11013, Mar. 26, 1990; 63 FR 16685, Apr. 6, 1998; 64 FR 26287, May 14, 1999]