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tangnaijie新虫 (初入文坛)
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[交流]
【求助】关于FDA认可的染料
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一般FDA 认可的那些可以使用的染料 在哪里可以查到它们具体的说明？或者说那里可以查到一些关于染料的资料。我们正在使用一种染料，我FDA中查到是认可的。 但是我们不清楚它的要求。所以无法制定质量要求。 附一份供应商的COA报告，不清楚上面的东西，希望懂的同志们可以给予一些解释。 [ Last edited by zhjf on 2008-11-19 at 15:55 ] |
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FDA 技术指标 [Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2002] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR74.1206] [Page 400-401] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents Subpart B--Drugs Sec. 74.1206 D&C Green No. 6. (a) Identity. The color additive D&C Green No. 6 is 1,4-bis[(4- methylphenyl)amino]-9,10-anthracenedione (CAS. Reg. No. 128-80-3). (b) Specifications. The color additive D&C Green No. 6 for use in coloring externally applied drugs shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practice: Volatile matter (at 135 [deg]C), not more than 2.0 percent. Water-soluble matter, not more than 0.3 percent. Matter insoluble in carbon tetrachloride, not more than 1.5 percent. p-Toluidine, not more than 0.1 percent. 1,4-Dihydroxyanthraquinone, not more than 0.2 percent. 1-Hydroxy-4-[(4-methylphenyl)amino]-9, 10-anthracenedione, not more than 5.0 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 96.0 percent. (c) Uses and restrictions. The color additive D&C Green No. 6 may be safely used for coloring externally applied drugs in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive shall conform to the requirements of Sec. 70.25 of this chapter. [[Page 401]] (e) Certification. All batches of D&C Green No. 6 shall be certified in accordance with regulations promulgated under part 80 of this chapter. [42 FR 15654, Mar. 22, 1977, as amended at 47 FR 14146, Apr.2, 1982; 47 FR 24278, June 4, 1982; 51 FR 9784, Mar. 21, 1986] |
2楼2009-02-08 07:44:50