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1.02735 SAFC

L-Cysteine hydrochloride monohydrate

EMPROVE® ESSENTIAL Ph Eur,USP

Synonym: Cys, L-Cysteinium Chloride Monohydrate, L-Cysteine Hydrochloride, Monohydrate

  • CAS Number 7048-04-6

  • Linear Formula HSCH2CH(NH2)COOH · HCl · H2O

  • Molecular Weight 175.63

  •  Beilstein/REAXYS Number 5158059

  •  MDL number MFCD00065606

  •  EC Index Number 200-157-7

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Properties

Related Categories Amino Acids, Biochemicals and Reagents, Biopharmaceutical Manufacturing, Biopharmaceutical Process Development and Manufacturing, Cell Culture Ingredients and Supplements for Biopharmaceutical Manufacturing More...
Agency/Method   Ph. Eur.
  USP
Quality Level   500
vapor pressure   <0.1 hPa ( 20 °C)
product line   EMPROVE® Essential
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
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
storage conditions   Store at +5°C to +30°C.

Description

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.

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