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品質水準
詳細
EMPROVE® EXPERT DAB,USP
製品種目
EMPROVE® EXPERT
形状
solid
有効性
7500 mg/kg LD50, oral (Rat)
テクニック
API processing | cocrystal formation: suitable
API processing | salt formation: suitable
pH
4.0-6.0 (20 °C, 25 g/L in H2O)
mp
185 °C (dec.) (lit.)
溶解性
100 g/L
密度
1.47 g/cm3 at 20 °C
かさ密度
640 kg/m3
保管温度
2-30°C
SMILES記法
N[C@@H](CCC(N)=O)C(O)=O
InChI
1S/C5H10N2O3/c6-3(5(9)10)1-2-4(7)8/h3H,1-2,6H2,(H2,7,8)(H,9,10)/t3-/m0/s1
InChI Key
ZDXPYRJPNDTMRX-VKHMYHEASA-N
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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.
生物化学的/生理学的作用
L-グルタミンは、培養細胞の主なエネルギー源となる重要な培地成分である必須アミノ酸です。L-グルタミンは、乾燥粉末および凍結溶液の状態で非常に安定です。しかし、液体培地やストック溶液において、L-グルタミンは比較的速く分解します。最適な細胞の性能には通常、使用前の培地へのL-グルタミンの添加が必要です。
アナリシスノート
Assay (perchloric acid titration, calculated on dried substance)99.0 - 101.0 %Identity (IR-spectrum)passes testAppearancewhite to almost white, fine powderAppearance of solution (25 g/l; CO₂-free water)clear and colorlessSpec. rotation (α 20/D, 100 g/l, hydrochloric acid 2 mol/l, calc. on dried substance)+31.5 to +33.0Spec. rotation (α 20/D, 40 g/l, water, calc. on dried substance)+6.3 to +7.3pH (25 g/l; CO₂-free water)4.0 - 6.0Chloride (Cl)≤ 200 ppmSulfate (SO₄)≤ 200 ppmHeavy metals (as Pb)≤ 10 ppmCu (Copper)≤ 25 ppmFe (Iron)≤ 10 ppmFe (Iron) (ICP)≤ 10 ppmMn (Manganese)≤ 25 ppmNi (Nickel)≤ 2 ppmZn (Zinc)≤ 130 ppmNH₄ (Ammonium)≤ 0.1 %Ninhydrin - positive substances (TLC)≤ 0.5 %Residual solvents (ICH Q3C)excluded by manufacturing processSulfated ash (600 °C)≤ 0.1 %Loss on drying (105 °C; 3 h)≤ 0.3 %Bacterial endotoxins≤ 2.0 I.U./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 DAB, 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
試験成績書(COA)
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