1.02735

L-Cysteine hydrochloride monohydrate

EMPROVE^® EXPERT, Ph. Eur., JP, USP

• Synonim(y): Cys, L-Cysteinium Chloride Monohydrate, L-Cysteine Hydrochloride, Monohydrate
• Wzór liniowy: HSCH₂CH(NH₂)COOH · HCl · H₂O
• Numer CAS: 7048-04-6
• Masa cząsteczkowa: 175.63
• EC Index Number: 200-157-7
• UNSPSC Code: 12352209
• Beilstein/REAXYS Number: 5158059
• MDL number: MFCD00065606

Właściwości

• Quality Segment: 500
• agency: JP, Ph. Eur., USP
• 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 (SO₄^2-): ≤300 ppm
• cation traces: Fe: ≤20 ppm, heavy metals (as Pb): ≤10 ppm
• application(s): biomolecule formulation; downstream processes; downstream processes; liquid formulation; pharma/biopharma processes; pharma/biopharma processes
• storage temp.: 2-30°C
• 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

Opis

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.

Biochem/physiol Actions

NMDA glutamatergic receptor antagonist.

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.

Legal Information

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

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

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Informacja o środkach bezpieczeństwa

• Klasa składowania: 11 - Combustible Solids
• Co się dzieje?: WGK 1
• Temperatura zapłonu (°F): Not applicable
• Temperatura zapłonu (°C): Not applicable