ssw (swa_) — Translations

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Over 5 years ago Female 30s

Japan

Japanese (Native) English

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English → Japanese 31 Oct 2019 at 13:48
Original Text 6 Background: The acceptance criteria of 0.5 mm for metal particles is also often applied at drug product manufacturers for in-line metal detectors/metal separators. 7 Justification for very small particles: see Ref.h); for inert particles >0,2 mm, as they are not dissolved and not absorbed in the gastrointestinal gut: see Ref.i) 8 Justification: limit is based on experience and practicality of this test to detect about 2 ppm charcoal on a filter with about 25 to 50 mm diameter 9 Remark: It is recognized that particles might only be identified as metals by applying specific analytical techniques	Translation 6 背景 : 金属粒子の0.5 mmという判定基準は、インライン式金属検出器/金属セパレータの製剤メーカーでもしばしば適用される。 7 非常に小さい粒子の根拠 : 2mmを超える不活性粒子（h)参照）については、消化管で溶解されず、吸収されない。（i)参照） 8 妥当性 : 限界は直径約25~50mmのフィルター上で約2ppmの石炭を検出するこの試験の経験と実用性に基づく。 9 備考 : 特定の分析技術を適用することによって、粒子は金属であると証明されるだけかもしれないと認められる。

English → Japanese

31 Oct 2019 at 13:48

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