L-Cysteine.97%,100g

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

Manufacturer: Merck

Catalog ID: 102735.0100

Stock: In Stock

 

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

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

Storage and Shipping Information

Storage Store at +5°C to +30°C.

Specifications

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
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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