做食品FDA注册需要的流程
fda 21cfr,食品接触材料检测标准,hk
a. 21cfr 177.1040 acrylonitrile/styrene copoly-mer(as)丙烯晴-苯乙烯共聚物
i) maximum residual acrylonitrile monomer content
ii) nitrogen content of the copolymer
iii) total non-volatile extractives in distilled water
iv) total non-volatile extractives in 3% acetic acid
v) the extracted copolymer in distilled water
vi) the extracted copolymer in 3% acetic acid
b. 21cfr 177.1020 acrylonitrile/butadiene/styrene co-polymer( abs)
丙烯酸-丁二烯-苯乙烯树脂共聚物
i) nitrogen content of the copolymer
ii) residual acrylonitrile monomer content
iii) total non-volatile extractives in distilled water
iv) total non-volatile extractives in 3%acetic acid
v) total non-nvolatile extractives in n-heptane
vi) acrylonitrile monomer migration in distilled water
vii) acrylonitrile monomer migration in 3%acetic acid
c. 177.1460 melamine-formaldehyde resins in molded articles (mf) 密胺/甲醛树脂
i) net chloroform-soluble extractives in distilled water
ii) net chloroform-soluble extractives in n-heptane
iii) net chloroform-soluble extractives in 8% alcohol
d. 177.1500 nylon resins 尼龙树脂
i) specific gravity
ii) melting point
iii) solubility in boiling 4.2nhcl
iv) maxium extractable fraction in water
v) maxium extractable fraction in 95% alcohol
vi) maxium extractable fraction in ethyl acetate
viii) maxium extractable fraction in benzene
e. polyethylene resins (pe) , 21 cfr 177.1520 聚乙烯树脂
i) density
ii) extractable fraction in n-hexane
iii) soluble fraction in xylene
f. polypropylene resins (pp) , 21 cfr 177.1520 聚丙烯树脂
'i) density
ii) melting point
iii) extractable fraction in n-hexane
iv) soluble fraction in xylene
g.ethylene-vinyl acetate copolymer (eva), 21 cfr 177.1350乙烯/乙酸乙酯共聚物
i) total extractives in distilled water
ii) total extractives in n-heptane
iii) total extractives in 8% alcohol
iv) total extractives in 50% alcohol
h. polycarbonate resins (pc), 21 cfr 177.1580聚碳酸酯
i) total extractives in distilled water
ii) total extractives in 50% ethyl alcohol
iii) total extractives in n-heptane
i. polyethylene phthalate polymers (polyester, e.g. pet), 21 cfr 177.1630苯二甲酸乙二酯
i) chloroform-soluble extractives in distilled water
ii) chloroform-soluble extractives in n-heptane
iii) chloroform-soluble extractives in 50% ethyl alcohol
j. polyvinyl alcohol film, 21 cfr 177.1670 聚乙烯醇薄膜
i) total extractives in n-heptane
k. polyoxymethylene copolymer (pom), 21 cfr 177.2470 聚甲醛树脂
i) net-chloroform soluble extractives in distilled water
ii) net-chloroform soluble extractives in n-heptane
iii) net-chloroform soluble extractives in 8% alcohol
iv) total extractives in distilled water at reflux temperature for 6 hours
v) total extractives in n-heptane at reflux temperature for 6 hours
l. polyphenylene sulphide (pps), 21 cfr 177.2490 聚苯硫醚树脂
i) total extractives in distilled water
ii) total extractives in 3% acetic acid
iii) total extractives in 50% ethanol
iv) total extractives in heptane
m. poly (2,6-dimethyl-1,4-phenylene) oxide (ppo), 21 cfr 177.2460 聚氧化树脂
i) total extractives in n-heptane
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