---
kind: "section"
citation: "9 C.F.R. § 113.105"
title: "9"
number: "113.105"
heading: "Leptospira Hardjo Bacterin."
url: "https://uscodex.org/cfr/9/113.105"
---

# §113.105. Leptospira Hardjo Bacterin.


Leptospira Hardjo Bacterin shall be produced from a culture of Leptospira hardjo which has been inactivated and is nontoxic. Each serial of biological product containing Leptospira hardjo fraction shall meet the applicable requirements in [§ 113.100](/cfr/9/113.100.md) and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.

- (a) **Purity test.** Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in [§ 113.26](/cfr/9/113.26.md).
- (b) **Safety test.** Bulk or final container samples of completed product from each serial shall be tested for safety as provided in [§ 113.38](/cfr/9/113.38.md).
- (c) **Potency test.** Bulk or final container samples of completed product from each serial shall be tested for potency using the test written into the filed Outline of Production.

## Notes

### Amendments

[40 FR 17003, Apr. 16, 1975, as amended at 40 FR 20067, May 8, 1975. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991]

### Authority

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

### Source

Source: 34 FR 18004, Nov. 7, 1969, unless otherwise noted.

### Amendments

[40 FR 17003, Apr. 16, 1975, as amended at 40 FR 20067, May 8, 1975. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991]