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December 18, 1989 Ralph Purtell CL-OTM-3 SUBJECT: GEONS 191 AND 198 - FDA STATUS Geons 191 and 198 are homopolymer polyvinyl chloride (PVC) resins. Polyvinyl chloride is prior sanctioned for use in general food contact applications, both flexible and rigid. The prior sanction is based on an article by A. J. Lehman, from the FDA, published in the Journal of the Association of Food and Drug Officials. July, 1951. The current Good Manufacturing Practice (GMP) specifications for prior sanctioned PVC are a maximum volatility of 3.0% (1 hour at 105C) and an inherent viscosity of not less than 0.35 by ASTM D-1243-79. Providing Geons 191 and 198 meet the GMP specifications for prior sanctioned PVC, they meet the current requirements of the FDA for general food contact applications including food wraps. PVC is also listed as an acceptable ingredient of food contact articles under 21CFR: 175.105 175.300 176.180 177.1010 177.1200 177.2250 179.45 21CFR Sections 300 to 400 cover drugs. There is no Section 477. Sections 461-499 are reserved for future use (see attached). 91024-3/jp 22146001 BFG19057 s s qa e 'rP rS s Bir? P 8ass 4 21 OR Gh I (*-1-09 NM", potency of each diluted solution la ... Isfactory If it is not lew than 90 nT cent and not more than 140 percents the number of microcrama of methoxasole that It is represented ^ contain. The pH of the solution con! lining 760 microframs of sulfamatK oxaxole per millfliter is not lesathSr 9.0 and not more than 12.5. The suif? methoxasole used conforms to th* standards prescribed by the Nation,? Formulary. (2) Labeling. It shall be labeled in accordance with the requirements of { 432.5 of this chapter. (3) Regueat* for certification; tan. plea In addition to complylnc with the requirements of 1431.1 of this eh.B ter. each such request shall contain. (1) Results of tests and assays on the batch for potency and pH. (11) Samples required: A miniwn1m Q. five frozen aliquots of each dilution of the concentrated stock solutions, each containing at least 10 milliliters. (b) Tests and method* of assay. The sample solutions must be thawed and brought to room temperature before testing. (1) Potency. Dilute aliquots of each sample in sufficient distilled water to make solutions containing 10 micro* grams of sulfamethoxasole per nuu. ter. Place approximately 100 milli grams of the standard, accurately weighed. Into a 100-milliliter volumet ric flask and make to volume with 0.1IV sodium hydroxide. Plpet 1.0 milli liter of this solution Into a 100-mlllili. ter volumetric flask and make to volume with distilled water. Using a suitable spectrophotometer equipped with 1.0 centimeter cells, and distilled water as the blank, determine the ab sorbance of sample and standard solu tions at 257 nanometers. Calculate the potency of the sulfamethoxasole as follows: Micragraas of sulfamsthoxasots par milliliter-sample abaorbanee tlmas weight of standard (In meg) tlmas/ times purity of standard In percent divided by standard ab sorbance timer 100 timer 100 where: /-Dilution factor of each wuwpla eolutVm (2) pH. Proceed as directed tat i 436.202 of this chapter, using the so- f figed eed Drug AdadnisfreMeii, HHS lotto0 containing 760 microgrmms of julfamethoxaaola per milliliter. 440.152 ttor.'alwSi14"' 10' 1W* 41 "* PAKTS 461--499 [USttVfOJ I z i 8? *r ? sf&'srn. _________irT i t 22146002 BFG19058