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§177.1655 聚砜类树脂(Polysulfone resins)
2011-10-11 19:25  点击:3611
发布单位:FDA
发布文号:61 FR 29475
发布日期:1996-06-11
生效日期:暂无
有效性状态:
废止日期:暂无
备注:本节规定了聚砜类树脂的合成方法,并规定了基本聚砜类树脂在其生产中可添加的辅料包括174.5(d)中所述的物质以及二甲基亚砜、一氯代苯、N-甲基-2-吡咯烷酮。当聚砜类树脂分别用50%(体积分数)乙醇/蒸馏水、3%乙酸/蒸馏水和正庚烷在回流温度下浸提6h,在每一浸提溶液中,总浸提物量均不得超过0.05mg/in2树脂表面。在本章176.170(c)中的表2中A至H的使用条件下,聚砜类树脂可重复用于接触食品。

     §177.1655 Polysulfone resins

      Polysulfone resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions:

  (a) For the purpose of this section, polysulfone resins are:

  (1) Poly(oxy-p -phenylenesulfonyl-p -phenyleneoxy-p -phenyleneisopropylidene-p -phenylene) resins (CAS Reg. No. 25154-01-2) consisting of basic resins produced when the disodium salt of 4,4′-isopropylidenediphenol is made to react with 4,4′-dichlorodiphenyl sulfone in such a way that the finished resins have a minimum number average molecular weight of 15,000, as determined by osmotic pressure in monochlorobenzene; or

  (2) 1,1′-Sulfonylbis[4-chlorobenzene] polymer with 4,4′-(1-methylethylidene)bis[phenol] (minimum 92 percent) and 4,4′-sulfonylbis[phenol] (maximum 8 percent) (CAS Reg. No. 88285-91-0) produced when a mixture of 4,4′-isopropylidenediphenol (minimum 92 percent) and 4,4′-sulfonylbis[phenol] (maximum 8 percent) is made to react with 4,4′-dichlorodiphenyl sulfone in such a way that the finished resin has a minimum number average molecular weight of 26,000, as determined by osmotic pressure in dimethylformamide.

  (b) The basic polysulfone resins identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic resins. The optional adjuvant substances required in the production of the basic polysulfone resins may include substances described in § 174.5(d) of this chapter and the following:
 

List of substances Limitations
Dimethyl sulfoxide  Not to exceed 50 parts per million as residual solvent in finished basic resin in paragraph (a)(1) of this section.
Monochlorobenzene  Not to exceed 500 parts per million as residual solvent in finished basic resin in paragraph (a)(1) of this section.
N-methyl-2-pyrrolidone  Not to exceed 0.01 percent (100 parts per million) as residual solvent in finished basic resin in paragraph (a)(2) of this section.



  (c) Polysulfone resins, when extracted at reflux temperatures for 6 hours with the solvents—distilled water, 50 percent (by volume) ethyl alcohol in distilled water, 3 percent acetic acid in distilled water, and n- heptane, yield total extractives in each extracting solvent not to exceed 0.0078 milligram per square centimeter (0.05 milligram per square inch) of resin surface. Note: In testing the finished polysulfone resins, use a separate resin test sample for each required extracting solvent.

  (d) Polysulfone resins intended for repeated use in contact with food may be used under conditions of use A through H in table 2 of § 176.170(c) of this chapter. The resins intended for single-service food-contact use may be used only under condition of use H described in table 2 of § 176.170(c) of this chapter.

    [51 FR 882, Jan. 9, 1986; 51 FR 4165, Feb. 3, 1986; 61 FR 29475, June 11, 1996]

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