9 CFR § 113.105 - Leptospira Hardjo Bacterin.

---
identifier: "/us/cfr/t9/s113.105"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "9 CFR § 113.105 - Leptospira Hardjo Bacterin."
title_number: 9
title_name: "Animals and Animal Products"
section_number: "113.105"
section_name: "Leptospira Hardjo Bacterin."
chapter_name: "ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE"
subchapter_number: "E"
subchapter_name: "VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS"
part_number: "113"
part_name: "STANDARD REQUIREMENTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4."
regulatory_source: "34 FR 18004, Nov. 7, 1969, unless otherwise noted."
cfr_part: "113"
---


# 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 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.

(b) *Safety test.* Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(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.

[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]