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L-Cysteine hydrochloride monohydrate

L-Cysteine hydrochloride monohydrate

suitable for use as excipient EMPROVE® exp Ph Eur,USP
Code: 1027350100
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suitable for use as excipient EMPROVE® exp Ph Eur,USP

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
7048-04-6 200-157-7 C₃H₈ClNO₂S * H₂O 175.64 g/mol

Ph Eur,USP

 

Description
Catalogue Number 102735
Synonyms Cys, L-Cysteinium Chloride Monohydrate, L-Cysteine Hydrochloride, Monohydrate
Product Information
CAS number 7048-04-6
EC number 200-157-7
Grade Ph Eur,USP
Hill Formula C₃H₈ClNO₂S * H₂O
Molar Mass 175.64 g/mol
HS Code 2930 90 16
Structure formula Image
Physicochemical Information
Melting Point 168 - 170 °C
pH value 0.8 - 1.2 (100 g/l, H₂O, 20 °C)
Bulk density 780 kg/m3
Solubility 650 g/l
Safety Information according to GHS
RTECS HA2285000
Storage class 10 - 13 Other liquids and solids
WGK WGK 1 slightly water endangering
Disposal 3
Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
Storage and Shipping Information
Storage Store at +5°C to +30°C.
Specifications
Assay (iodometric, calc. 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
Sulphate (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.
Specifications
Assay (iodometric, calc. 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
Sulphate (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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