FDAJ(rn)C
FDAJ(rn)C
FDAʳƷˎ֣Food and Drug AdministrationĺQFDALJHʳƷˎ˵ę(qun)C(gu)(lin)ڙ(qun)TʳƷcˎƷ߈(zh)CP(gun)һt(y)ɎW(xu)ˎW(xu)W(xu)Һͽy(tng)ӋW(xu)ҵȌI(y)ʿMɵڱoM߇l(wi)ƵıO(jin)ؙC(gu)
ʳƷˎ֣FDAܣʳƷˎƷFˎt(y)еʳƷӄyƷʳƷˎƷƾ7%ѾԼӮa(chn)ƷıO(jin)za(chn)ƷʹûM^Юa(chn)xxݗӰͰȫĿĜyԇzͳC(j)Ҏ(gu)a(chn)Ʒ횽(jng)^FDAzCȫЈNFDAЙ(qun)a(chn)SMҕЙ(qun)`V
FDAJ(rn)Cx͵λ
FDAJ(rn)CȫJ(rn)njwЧ܉_ȫĮa(chn)ƷǮa(chn)ƷƷ|(zh)cЧȫߘ(bio)(zhn)C
FDA`(w)Ժc(w)Ĺ(w)M߱oC(gu)
1990ԺFDAcISOMȇHMкƄһB´ʩʳƷˎƷI(lng)FDAJ(rn)CɞʳƷˎƷߙzy(bio)(zhn)l(wi)MJ(rn)ʳƷȫ(bio)(zhn)ֻĮa(chn)Ʒ(jng)^wʹîa(chn)Ʒ143P(gun)IzycλO(jin)y2-3f˳m(x)3-7ıO(jin)yȫͨ^ϸĮa(chn)Ʒŕ˰l(f)FDAJ(rn)CHܶS̶@ FDA J(rn)Ca(chn)ƷƷ|(zh)ߘsuͱC
FDAHNSCHFDAJ(rn)CeJ(rn)CQ(mo)MWTO˶P(gun)ʳƷˎƷͨJ(rn)CΨһͨ^FDAQ(mo)Mȫ˶ſɰl(f)ŵJ(rn)CCһ@J(rn)Ca(chn)ƷͨMκWTOɆTңBNģʽڇøA(y)
FDAȫИOӰ˽o֮QrFDAѳɞȫʳƷˎƷMеĽ
FDAJ(rn)C
ʳƷFDAJ(rn)Ck£
1ԃ---Ոṩa(chn)ƷYψDƬͨ^fҪՈFDAĮa(chn)Ʒ.
2r---(j)ՈṩYg(sh)̎u_횜yԇĿՈr
3Ո_J(rn)ryԇՈ͜yԇƷ
4ƷyԇyԇmõFDA(bio)(zhn)M
5yԇɺṩFDAJ(rn)C
ʳƷFDAJ(rn)C
ʳƷ|ָһڼӹa(chn)b惦\ݔʳƷ^cʳƷ܉|IJ.ҊIJϰNմľƷ@ЩcʳƷ܉|IJϵĭh(hun)ȫrֱP(gun)ʹߵʳȫͽԌ@a(chn)ƷڵҪFDA(bio)(zhn)MP(gun)ęzyJ(rn)C
ҊcʳƷ|FDAJ(rn)CzyĿ£
ЙCͿ, ٺƷҪU.S. FDA CFR 21 175.300.
ȥxˮȡ8%ƾȡȡ
ƷҪ U.S. FDA CFR 21 176.170
ȷ¿ȡȥxˮȡ8%ƾȡ50%ƾȡȡ
ľҪU.S. FDA CFR 21 178.3800
ȱPCP
ABSҪU.S. FDA CFR 21 181.32 or 180.22.
ȥxˮȡ3%ȡ8%ƾȡȡ
ϩ֬AcrylicҪU.S. FDA CFR 21 177.1010
ȡin water,8%,50%alcohol fraction,heptaneȥxˮ8%ƾ
KMnO4 oxidizable extractive(in water,8%,50%alcohol fraction)
Ultraviolet-absorbing(in water,8%,50%alcohol fraction)
Ultraviolet-absorbing(in heptane fraction)
ʳƷܷȦܷr|ҪzȦ U.S. FDA CFR 21 177.1210
ȷ¿ȡ
EVAҪ U.S. FDA CFR 21 177.1350
ȷȡ
谱֬(ܰ)Ҫ U.S. FDA CFR 21 177.1460
ȷ¿ȡ
Ҫ U.S. FDA CFR 21 177.1500
ܶc}еܽȥxˮȡ95%ƾȡ֬ȡȡ
PPҪ U.S. FDA CFR 21 177.1520
ܶcȡױȡ ..
PE,OPҪ U.S. FDA CFR 21 177.1520
ܶȡױȡ
PCҪ.U.S. FDA CFR 21 177.1580
ˮȡ50%ƾȡȡ
PETҪ U.S. FDA CFR 21 177.1630 .
ȷ¿ȡȥxˮȡ8%ƾȡ95%ƾȡȡ
PS Ҫ U.S. FDA CFR 21 177.1640
ϩw
ۗ֬Polysulfone resinҪ U.S. FDA CFR 21 177.1655
ȥxˮȡ3%ȡ50%ƾȡȡ
ہ֬PUҪ U.S. FDA CFR 21 177.1680
ĥyԇȥxˮȡ8%ƾȡ
ϩҪStyrene block polymer U.S. FDA CFR 21177.1810
ȥxˮȡ50%ƾȡܽD(zhun)׃ض
MMAMBSҪ.. U.S.FDA CFR 21 177.1830
Non-volatile residue
KmnO4 oxidized water extractives
KmnO4 oxidized 8% ethanol extractives
UV absorbing water extractives
UV absorbing 8% ethanol extractives
UV absorbing n-heptane extractives
ȩ֬UFҪ U.S. FDA CFR 21 177.1900
ȥxˮȡ8%ƾȡȡ
PVCҪ U.S. FDA CFR 21 175.300
ȥxˮȡȡ8%ƾȡVCMw
֬֬Polyester resinҪ U.S. FDA CFR 21 177.2420
ȷ¿ȡ
zҪSBS,TPR,TPEzȏw U.S. FDA CFR 21 177.2600
ȥxˮȡȡ(ֻᘌ֬ʳ|)
yƷҪ U.S. FDA CPG 7117.05
Uȡ
մ´Ҫ U.S. FDA CPG 7117.06,07
ܳUkyԇ
Ҫ U.S. FDA CFR 175.300 & CPG 7117.05
ȥxˮȡ8%ƾȡȡUȡ
FDAIJTMc
ʳƷˎƷO(jin)֣FDAw(lin)l(wi)(w)ݠּڱoʹMҹl(wi)λRmݵȫپSȺuͲʮ߀ڰЇڃ(ni)Ķ_O(sh)kC(gu)
ԓɂTMɣÿTؓ(f)؟(z)һP(gun)I(lng)ıO(jin)ܹ
TkңOC
ˎƷuоģCDER
ƷuоģCBER
ʳƷȫ͑(yng)àIB(yng)ģCFSAN
O(sh)xc佡ģCDRH
FˎģCVM
ҶW(xu)оģNCTR
O(jin)(w)kңORA
ʳƷˎƷO(jin)Ҳͬr(nng)I(y)(lin)P(gun)MƷȫίT(lin)TԼչ_lVĺ