Page 1
`
`21 C.F.R. § 610.13
`
`CODE OF FEDERAL REGULATIONS
`TITLE 21—FOOD AND DRUGS
`CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SER-
`VICES
`SUBCHAPTER F—BIOLOGICS
`PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS
`SUBPART B—GENERAL PROVISIONS
`© 1998 West, a Thomson business. No claim to original U.S. Govt. works
`Current through April 1, 1998, 63 FR 16076
`
`§ 610.13 Purity.
`
`Products shall be free of extraneous material except that which is unavoidable in the manufacturing process
`described in the approved license. In addition, products shall be tested as provided in paragraphs (a) and (b) of
`this section.
`(a)(1) Test for residual moisture. Each lot of dried product shall be tested for residual moisture and shall meet
`and not exceed established limits as specified by an approved method on file in the product license application.
`The test for residual moisture may be exempted by the Director, Center for Biologics Evaluation and Research,
`when deemed not necessary for the continued safety, purity, and potency of the product.
`(2) Records. Appropriate records for residual moisture under paragraph (a)(1) of this section shall be prepared
`and maintained as required by the applicable provisions of §§ 211.188 and 211.194 of this chapter.
`(b) Test for pyrogenic substances. Each lot of final containers of any product intended for use by injection shall
`be tested for pyrogenic substances by intravenous injection into rabbits as provided in paragraph (b)(1) and (2)
`of this section: Provided, That notwithstanding any other provision of Subchapter F of this chapter, the test for
`pyrogenic substances is not required for the following products: Products containing formed blood elements;
`Cryoprecipitate; Plasma; Source Plasma; Normal Horse Serum; bacterial, viral, and rickettsial vaccines and anti-
`gens; toxoids; toxins; allergenic extracts; venoms; diagnostic substances and trivalent organic arsenicals.
`(1) Test dose. The test dose for each rabbit shall be at least 3 milliliters per kilogram of body weight of the rab-
`bit and also shall be at least equivalent proportionately, on a body weight basis, to the maximum single human
`dose recommended, but need not exceed 10 milliliters per kilogram of body weight of the rabbit, except that: (i)
`Regardless of the human dose recommended, the test dose per kilogram of body weight of each rabbit shall be at
`least 1 milliliter for immune globulins derived from human blood; (ii) for Streptokinase, the test dose shall be at
`least equivalent proportionately, on a body weight basis, to the maximum single human dose recommended.
`(2) Test procedure, results, and interpretation; standards to be met. The test for pyrogenic substances shall be
`performed according to the requirements specified in United States Pharmacopeia XX.
`(3) Retest. If the lot fails to meet the test requirements prescribed in paragraph (b)(2) of this section, the test
`may be repeated once using five other rabbits. The temperature rises recorded for all eight rabbits used in testing
`shall be included in determining whether the requirements are met. The lot meets the requirements for absence
`of pyrogens if not more than three of the eight rabbits show individual rises in temperature of 0.6° C or more,
`and if the sum of the eight individual maximum temperature rises does not exceed 3.7° C.
`
`© 2015 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`
`1 of 2
`
`FRESENIUS-KABI, Exh. 1036
`
`

`
`Page 2
`
`(Information collection requirements were approved by the Office of Management and Budget (OMB) and as-
`signed OMB control number 0910-0139)
`
`[38 FR 32056, Nov. 20, 1973, as amended at 40 FR 29710, July 15, 1975; 41 FR 10429, Mar. 11, 1976; 41 FR
`41424, Sept. 22, 1976; 44 FR 40289, July 10, 1979; 46 FR 62845, Dec. 29, 1981; 49 FR 15187, April 18, 1984;
`50 FR 4134, Jan. 29, 1985; 55 FR 28381, July 11, 1990]
`21 C. F. R. § 610.13
`21 CFR § 610.13
`
`END OF DOCUMENT
`
`© 2015 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`
`2 of 2