1.02735
L-システイン 塩酸塩 一水和物
EMPROVE® EXPERT, Ph. Eur., JP, USP
別名:
Cys, L-Cysteinium Chloride Monohydrate, L-Cysteine Hydrochloride, Monohydrate
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この商品について
化学式:
HSCH2CH(NH2)COOH · HCl · H2O
CAS番号:
分子量:
175.63
EC Index Number:
200-157-7
UNSPSC Code:
12352209
Beilstein/REAXYS Number:
5158059
MDL number:
製品名
L-システイン 塩酸塩 一水和物, EMPROVE® EXPERT, Ph. Eur., JP, USP
agency
JP
Ph. Eur.
USP
SMILES string
O.Cl.N[C@@H](CS)C(O)=O
InChI
1S/C3H7NO2S.ClH.H2O/c4-2(1-7)3(5)6;;/h2,7H,1,4H2,(H,5,6);1H;1H2/t2-;;/m0../s1
InChI key
QIJRTFXNRTXDIP-JIZZDEOASA-N
vapor pressure
<0.1 hPa ( 20 °C)
product line
EMPROVE® EXPERT
assay
98.5-101.0% dry basis (alkalimetric)
form
crystalline powder
pH
0.8-1.2 (20 °C, 100 g/L in H2O)
mp
168-170 °C
solubility
650 g/L
density
1.54 g/cm3
bulk density
780 kg/m3
anion traces
sulfate (SO42-): ≤300 ppm
cation traces
Fe: ≤20 ppm
heavy metals (as Pb): ≤10 ppm
storage temp.
2-30°C
Quality Level
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Biochem/physiol Actions
N-メチル-D-アスパラギン酸(NMDA)型グルタミン酸作動性受容体のアゴニストです。
Analysis Note
Assay (alkalimetric, calculated on dried substance): 98.5 - 101.0 %
Identity (IR-spectrum): passes test
Identity (Chloride): passes test
Appearance: white to almost white crystalline powder or colorless crystals
Appearance of solution (25 g/l, water): clear and not more intense in color than reference solution BY₆
Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance): +5.5 to +7.0
Spec. rotation (α 25/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance): +5.7 to +6.8
Sulfate (SO₄): ≤ 300 ppm
Heavy metals (as Pb): ≤ 10 ppm
Fe (Iron): ≤ 20 ppm
Related Compounds, total (TLC): ≤ 0.5 %
Ninhydrin-positive substances (LC)(impurity A (570 nm)): ≤ 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): ≤ 1.0 %
Residual solvents (ICH Q3C): excluded by manufacturing proces
Sulfated ash (600 °C): ≤ 0.1 %
Loss on drying (Vacuum < 0.7 kPa, P₂O₅, 24 h): 8.0 - 12.0 %
Bacterial endotoxins: ≤ 6.0 I.U./g
Elemental 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.
Identity (IR-spectrum): passes test
Identity (Chloride): passes test
Appearance: white to almost white crystalline powder or colorless crystals
Appearance of solution (25 g/l, water): clear and not more intense in color than reference solution BY₆
Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance): +5.5 to +7.0
Spec. rotation (α 25/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance): +5.7 to +6.8
Sulfate (SO₄): ≤ 300 ppm
Heavy metals (as Pb): ≤ 10 ppm
Fe (Iron): ≤ 20 ppm
Related Compounds, total (TLC): ≤ 0.5 %
Ninhydrin-positive substances (LC)(impurity A (570 nm)): ≤ 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): ≤ 1.0 %
Residual solvents (ICH Q3C): excluded by manufacturing proces
Sulfated ash (600 °C): ≤ 0.1 %
Loss on drying (Vacuum < 0.7 kPa, P₂O₅, 24 h): 8.0 - 12.0 %
Bacterial endotoxins: ≤ 6.0 I.U./g
Elemental 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.
General description
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.
Legal Information
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
保管分類
11 - Combustible Solids
wgk
WGK 1
flash_point_f
Not applicable
flash_point_c
Not applicable
試験成績書（COA）
製品のロット番号・バッチ番号を入力して、試験成績書（COA） を検索できます。ロット番号・バッチ番号は、製品ラベルに「Lot」または「Batch」に続いて記載されています。
グローバルトレードアイテム番号
| カタログ番号 | GTIN |
|---|---|
| 1.02735.9010 | 04022536942636 |
| 1.02735.0100 | 04022536942612 |
| 1.02735.1000 | 04022536942629 |
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