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認証
JP
Ph. Eur.
USP
品質水準
製品種目
EMPROVE® EXPERT
有効性
>5110 mg/kg LD50, oral (Rat)
pH
5-7 (20 °C, 100 g/L in H2O)
mp
220-222 °C (decomposition)
溶解性
1500 g/L
密度
1.35-1.38 g/cm3 at 25 °C
かさ密度
500 kg/m3
アプリケーション
parenterals
保管温度
2-30°C
InChI
1S/C5H9NO2/c7-5(8)4-2-1-3-6-4/h4,6H,1-3H2,(H,7,8)
InChI Key
ONIBWKKTOPOVIA-UHFFFAOYSA-N
詳細
Our SAFC® portfolio of high-quality products for biopharmaceutical processing withstands strict quality control procedures and is produced according to MQ-500 requirements as defined by the M-Clarity program.
M-Clarity Program
As part of our EMPROVE® Program, our raw materials are offered with EMPROVE® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.
Our comprehensive portfolio of upstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for production of classical and novel therapies, but also helps them get to market faster and simplify regulatory challenges. Trust us to deliver supply chain transparency and reliable sourcing around the globe, streamlining your product qualification with best-in-class regulatory support and service.
M-Clarity Program
As part of our EMPROVE® Program, our raw materials are offered with EMPROVE® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.
Our comprehensive portfolio of upstream process chemicals not only provides biopharmaceutical manufacturers with high-quality raw materials for production of classical and novel therapies, but also helps them get to market faster and simplify regulatory challenges. Trust us to deliver supply chain transparency and reliable sourcing around the globe, streamlining your product qualification with best-in-class regulatory support and service.
アナリシスノート
Assay (perchloric acid titration, calculated on dried substance)99.0 - 101.0 %Identity (IR-spectrum)passes testIdentity (specific rotation)passes testAppearancewhite or almost white, crystalline powder or colorless crystalsAppearance of solution (50 g/l; water)clear and colorlessSpec. rotation (α 20/D, 40 g/l, water, calc. on dried substance)-84.0 to -86.0Spec. rotation (α 25/D, 40 g/l, water, calc. on dried substance)-84.3 to -86.3Chloride (Cl)≤ 200 ppmSulfate (SO₄)≤ 300 ppmFe (Iron)≤ 10 ppmMn (Manganese)≤ 25 ppmZn (Zinc)≤ 130 ppmRelated Compounds, total (TLC)≤ 0.5 %Ninhydrin-positive substances (LC)(any ninhydrin-positive impurity)≤ 0.2 %Ninhydrin-positive substances (LC) (ammonium (570 nm))≤ 0.02 %Ninhydrin-positive substances (LC)(total impurities)≤ 0.5 %Residual solvents (ICH Q3C)excluded by manufacturing processSulfated ash (600 °C)≤ 0.1 %Loss on Drying (105 °C)≤ 0.4 %Bacterial endotoxins≤ 5 I.U./gTotal aerobic microbial count (TAMC)≤ 100 CFU/gTotal combined yeasts/moulds count (TYMC)≤ 100 CFU/gElemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).Corresponds to Ph. Eur., USP.
法的情報
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
保管分類コード
13 - Non Combustible Solids
WGK
WGK 1
引火点(°F)
Not applicable
引火点(℃)
Not applicable
適用法令
試験研究用途を考慮した関連法令を主に挙げております。化学物質以外については、一部の情報のみ提供しています。 製品を安全かつ合法的に使用することは、使用者の義務です。最新情報により修正される場合があります。WEBの反映には時間を要することがあるため、適宜SDSをご参照ください。
Jan Code
CO1E1074301000:
1074300250:
1074309025:
1074309010:
1074300000:
1074301000:
試験成績書（COA）
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