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137139

SAFC

Cysteamine hydrochloride

EMPROVE® ESSENTIAL

Pharma Manufacturing

Synonym(s):

β-Mercapto­ethylamine hydrochloride, 2-Amino­ethane­thiol hydrochloride, 2-Mercapto­ethyl­amine hydrochloride, Decarboxy­cysteine hydrochloride, Thio­ethanol­amine hydrochloride

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About This Item

Linear Formula:
HSCH2CH2NH2 · HCl
CAS Number:
Molecular Weight:
113.61
Beilstein:
3590083
MDL number:
UNSPSC Code:
12352116

product line

EMPROVE® ESSENTIAL

Quality Level

form

solid

concentration

30.6-31.8 % (w/w) (T)
98.0-102.0 % (w/w) (GC)

impurities

≤0.3% each single unknown impurity
≤10 ppm heavy metals (sum of Ag, As, Bi, Cd, Cr, Cu, Hg, Mo, Ni, Pb, Sb, Sn)
≤2.0% cystamine dihydrochloride (GC)
≤5000 mg/kg TBME (HS-GC)
≤5000 mg/kg ethanol (HS-GC)

loss

≤1.0% loss on drying

mp

67-71 °C

cation traces

As: ≤1.5 ppm
Cd: ≤0.2 ppm
Co: ≤0.5 ppm
Cr: ≤110 ppm
Cu: ≤30 ppm
Hg: ≤0.3 ppm
Li: ≤25 ppm
Mo: ≤150 ppm
Ni: ≤2 ppm
Pb: ≤0.5 ppm
Sb: ≤9 ppm
V: ≤1 ppm

storage temp.

2-8°C

SMILES string

Cl[H].NCCS

InChI

1S/C2H7NS.ClH/c3-1-2-4;/h4H,1-3H2;1H

InChI key

OGMADIBCHLQMIP-UHFFFAOYSA-N

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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.

Analysis Note

Purity (GC) ≥98.0% (area)
Identity (H-NMR): corresponds to reference spectrum
Identity (GC): retention time corresponds to reference (±5%)

Legal Information

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

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Hazard Classifications

Acute Tox. 4 Oral - Eye Irrit. 2 - Skin Sens. 1 - STOT SE 3

Target Organs

Respiratory system

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Certificates of Analysis (COA)

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