寧波歐標檢測 美國FDA 服務中心,具備專業(yè)豐富的 FDA 服務經(jīng)驗。協(xié)助眾多經(jīng)營食品及接觸材料、藥品、海鮮、化妝護膚品、醫(yī)療器械等相關出口美國的企業(yè)成功將商品投入美國市場，幫助企業(yè)及時解決各類產(chǎn)品被扣留、被拒絕的疑難問題。協(xié)助企業(yè)遵守美國食品與藥品管理局（FDA）相關標準，為企業(yè)提供已履行FDA注冊要求的手續(xù)。

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  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-苯乙烯樹脂共聚物

    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/甲醛樹脂

    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 尼龍樹脂

    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 聚乙烯樹脂

    i) Density

    ii) Extractable fraction in n-hexane

    iii) Soluble fraction in xylene

    f. Polypropylene resins (PP) , 21 CFR 177.1520 聚丙烯樹脂

    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 聚甲醛樹脂

    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 聚苯硫醚樹脂

    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 聚氧化樹脂

    i) Total extractives in n-heptane 

    n. Rubber, 21 CFR 177.2600 橡膠，硅膠

    i) Total extractives in distilled water (intended to contact with aqueous food) for

    ii) Total extractives in n-hexane (intended to contact with fatty food) for

    o.Acrylonitrile copolymers, Single-use, 21 CFR 180.22丙烯晴共聚物

    i) Acrylonitrile monomer extraction for finished product in distilled water at 120°F forappropriate time of use

    ii) Acrylonitrile monomer extraction for finished product in 8% or 50% ethanol (selectone) at 120°F for appropriate time of use

    iii) Acrylonitrile monomer extraction for finished product in 3% acetic acid at 120°F forappropriate time of use

    iv) Acrylonitrile monomer extraction for finished product in n-heptane at 120°F forappropriate time of use

    P. Polystyrene resins(PS), 21 CFR 177.1640 聚苯乙烯

    i) Total residual styrene monomer content

    q. Resinous and polymeric coating, 21 CFR 175.300 樹脂和聚合物的涂料

    i) Total extractives in distilled water

    ii) Total extractives in 8% alcohol

    iii) Total extractives in n-heptane

    r. Phenolic resins in molded articles, 21 CFR 177.2410 酚醛樹脂

    i) Total extractives in distilled water

    ii) Extracted phenol in distilled water

    iii) Extracted aniline in distilled water

    s. Ion-exchange resins, 21 CFR 173.25 離子交換樹脂

    i) Organic extractives in distilled water

    ii) Organic extractives in 15% alcohol

    iii) Organic extractives in 5% acetic acid

    t. Reinforced wax, 21 CFR 178.3850密封蠟

    i) Chloroform-soluble portion in distilled water

    u. Per fluorocarbon Resins, 21 CFR 177.1550 特氟龍

    i) Total extractives in distilled water

    ii) Total extractives in n-heptane

    iii) Total extractives in 50% alcohol

    iv) Total extractives in ethyl acetate

    v) Fluoride extractives calculated as fluorine in distilled water

    vi) Fluoride extractives calculated as fluorine in n-heptane

    vii) Fluoride extractives calculated as fluorine in 50% alcohol

    viii) Fluoride extractives calculated as fluorine in ethyl acetate

    v. Closures with sealing gaskets for food containers, 21 CFR 177.1210 密封墊片

    i) Chloroform fraction of water extractives

    ii) Chloroform fraction of heptane extractives

    iii) Chloroform fraction of 8% alcohol extractives

 

    2. FDA Regulation for Paper and paperboard

    a. Paper and coated paper, 21CFR 176.170 +