Polyethylene glycol 400 BP, USP, NF, Reag. Ph. Eur., pharma grade

Supplier: PanReac AppliChem

Synonyms: PEG 400

142436.1214 142436.1611
APPC142436.1214EA 902 SGD
APPC142436.1214 APPC142436.1611
Polyethylene glycol 400 BP, USP, NF, Reag. Ph. Eur., pharma grade
Polyethylene glycol 400
Formula: H(OCH₂CH₂)nOH
MW: 400 g/mol
Melting Pt: 4…8 °C
Density: 1,127 g/cm³
Storage Temperature: Ambient
MDL Number: MFCD00081839
CAS Number: 25322-68-3
EINECS: 203-473-3

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Specification Test Results

Identity According to Pharmacopoeias Passes Test
pH of 5% Solution 4.5 - 7.5
Viscosity Dynamic at 20 °C 105 - 130 mPa
Viscosity Kinematic at 20 °C 94 - 116 cSt
Viscosity 98.9 ±0.3 °C 6.8 - 8.0 cSt
Average Molecular Weight 380 - 420 g/mol
Acidity or Alkalinity Passes Test
Insoluble Matter in H₂O Passes Test
Reducing Substances Passes Test
Residue on Ignition (as SO₄) Max. 0.1%
Hydroxyl Value Max. 264 - 300
Residual Solvents (Ph. Eur./USP) Passes Test
Ethylene Oxide (G.C.) Max. 0.0001%
1,4-Dioxan (G.C.) Max. 0.001%
Formaldehyde (CH₂O) Max. 0.0015%
Ethylene Glycol and Diethylene Glycol (G.C.) Max. 0.25%
Water (H₂O) Max. 2%
Heavy metals (as Pb) Max. 0.0005%
Cd, Class 1 - (ICH Q3D) Max. 0.5 ppm
Pb, Class 1 - (ICH Q3D) Max. 0.5 ppm
As, Class 1 - (ICH Q3D) Max. 1.5 ppm
Hg, Class 1 - (ICH Q3D) Max. 1.5 ppm
Co, Class 2A - (ICH Q3D) Max. 5 ppm
V, Class 2A - (ICH Q3D) Max. 10 ppm
Ni, Class 2A - (ICH Q3D) Max. 20 ppm
Tl, Class 2B - (ICH Q3D) Max. 5 ppm
Au, Class 2B - (ICH Q3D) Max. 10 ppm
Pd, Class 2B - (ICH Q3D) Max. 10 ppm
Ir, Class 2B - (ICH Q3D) Max. 10 ppm
Os, Class 2B - (ICH Q3D) Max. 10 ppm
Rh, Class 2B - (ICH Q3D) Max. 10 ppm
Ru, Class 2B - (ICH Q3D) Max. 10 ppm
Se, Class 2B - (ICH Q3D) Max. 15 ppm
Ag, Class 2B - (ICH Q3D) Max. 15 ppm
Pt, Class 2B - (ICH Q3D) Max. 10 ppm
Li, Class 3 - (ICH Q3D) Max. 55 ppm
Sb, Class 3 - (ICH Q3D) Max. 120 ppm
Ba, Class 3 - (ICH Q3D) Max. 140 ppm
Mo, Class 3 - (ICH Q3D) Max. 25 ppm
Cu, Class 3 - (ICH Q3D) Max. 250 ppm
Sn, Class 3 - (ICH Q3D) Max. 600 ppm
Cr, Class 3 - (ICH Q3D) Max. 25 ppm

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