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Merck

1.00286

SAFC

L-谷氨酰胺

EMPROVE® EXPERT, DAB, JP, USP

制药生产

别名:

(S)-2,5-二氨基-5-氧代戊酸, L-谷氨酸-5-酰胺, 左谷酰胺

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About This Item

线性分子式:
H2NCOCH2CH2CH(NH2)CO2H
CAS号:
分子量:
146.14
Beilstein:
1723797
MDL號碼:
分類程式碼代碼:
12352209
酶委員會索引編號:
200-292-1

agency

DAB
JP
USP

品質等級

描述

EMPROVE® EXPERT DAB,USP

產品線

EMPROVE® EXPERT

形狀

solid

效力

7500 mg/kg LD50, oral (Rat)

技術

API processing | cocrystal formation: suitable
API processing | salt formation: suitable

pH值

4.0-6.0 (20 °C, 25 g/L in H2O)

mp

185 °C (dec.) (lit.)

溶解度

100 g/L

密度

1.47 g/cm3 at 20 °C

體積密度

640 kg/m3

儲存溫度

2-30°C

SMILES 字串

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 密鑰

ZDXPYRJPNDTMRX-VKHMYHEASA-N

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一般說明

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.

生化/生理作用

L-谷氨酰胺是一种必需氨基酸,作为细胞培养过程中主要的能量来源而成为培养基的重要组分。L-谷氨酰胺在干粉及冷冻溶液的状态下极为稳定。然而,L-谷氨酰胺在液体培养基或储存溶液中均会相对较快的降解。最佳的细胞表现通常需要在使用前向培养基中添加L-谷氨酰胺补充剂。

分析報告

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

法律資訊

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

儲存類別代碼

13 - Non Combustible Solids

水污染物質分類(WGK)

WGK 1

閃點(°F)

Not applicable

閃點(°C)

Not applicable


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