Optional adjuvants.
Optional adjuvants. The optional adjuvant substances required in the production of resins identified in paragraph (a) of this section may include:
(1) Substances used in accordance with § 174.5 of this chapter.
(2) Substances identified in § 177.1580(b).
(3) Substances regulated in § 178.2010(b) of this chapter for use in polycarbonate resins complying with § 177.1580:
(1) Substances used in accordance with § 174.5 of this chapter.
(2) Substances identified in § 177.1580(b).
(3) Substances regulated in § 178.2010(b) of this chapter for use in polycarbonate resins complying with § 177.1580:
(c) Polyestercarbonate resins shall conform to the specifications prescribed in paragraph (c)(1) of this section and shall meet the extractive limitations prescribed in paragraph (c)(2) of this section.
(1) Specifications. Polyestercarbonate resins identified in paragraph (a) of this section can be identified by their characteristic infrared spectrum. The resins shall comply with either or both of the following specifications:
(i) The solution intrinsic viscosity of the polyestercarbonate resins shall be a minimum of 0.44 deciliter per gram, as determined by a method entitled “Intrinsic Viscosity (IV) of Lexan ® Polyestercarbonate Resin by a Single Point Method Using Dichloromethane as the Solvent,” developed by the General Electric Co., September 20, 1985, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS–215), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(ii) A minimum weight-average molecular weight of 27,000, as determined by gel permeation chromatography using polystyrene standards.
(2) Extractives limitations. The polyestercarbonate resins to be tested shall be ground or cut into small particles that will pass through a U.S. standard sieve No. 6 and that will be held on U.S. standard sieve No. 10.
(i) Polyestercarbonate resins, when extracted with distilled water at reflux temperature for 6 hours, shall yield total nonvolatile extractives not to exceed 0.005 percent by weight of the resins.
(ii) Polyestercarbonate resins, when extracted with 50 percent (by volume) ethyl alcohol in distilled water at reflux temperature for 6 hours, shall yield total nonvolatile extractives not to exceed 0.005 percent by weight of the resins.
(iii) Polyestercarbonate resins, when extracted with n-heptane at reflux temperature for 6 hours, shall yield total nonvolatile extractives not to exceed 0.002 percent by weight of the resins.
(3) Residual methylene chloride levels in polyestercarbonate resins. Polyestercarbonate resin articles in the finished form shall not contain residual methylene chloride in excess of 5 parts per million as determined by a method titled “Analytical Method for Determination of Residual Methylene Chloride in Polyestercarbonate Resin,” developed by the General Electric Co., July 23, 1991, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.