Kolliphor® P 188 (Lutrol® F68, Pluronic® F-68, Synperonic® F68, Poloxamer 188) stabilised, EMPROVE® EXPERT Ph. Eur., NF

Leverandør: MERCK PRODUCTION CHEMICALS
Ratings: Ingen bedømmelse

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Stabilization: stabiliseret med BHT/Ionol 70 ppm

1.37112.0001EA 0 DKK
1.37112.0001 1.37112.1000 1.37112.9025 1.37112.9010
Kolliphor® P 188 (Lutrol® F68, Pluronic® F-68, Synperonic® F68, Poloxamer 188) stabilised, EMPROVE® EXPERT Ph. Eur., NF
Kolliphor® P 188 (Lutrol® F68, Pluronic® F-68, Synperonic® F68, Poloxamer 188)
Formel: (C₃H₆O.C₂H₄O)x
Molekylvægt: 8400 g/mol
Smeltepunkt: 52 °C
Massefylde: 1,06 g/cm³ (70 °C)
Flammepunkt: 260 °C
Opbevaringstemperatur: Stue temperatur
MDL Number: MFCD00082049
CAS-nummer: 9003-11-6

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Specifikationer Testresultater

Identity (IR-Spectrum) Passes Test
Identity (Average Relative Molecular Mass) Passes Test
Content of Oxyethylene Moieties (H-NMR) 79.9-83.7%
Appearance White to Almost White, Waxy Substance
Appearance of Solution (100 g/l, CO2-free Water) Clear and not More Intense in Color than Reference Solution BY7
pH (25 g/l; CO₂-Free Water) 5.0 - 7.5
pH (100 g/l, CO₂-Free Water) 5.0 - 7.5
Average Relative Molecular Mass 7680 - 9510
Unsaturation 0.018 - 0.034 meq/g
Ethylene Oxide (HS-GC) ≤1 ppm
Dioxane (HS-GC) ≤5 ppm
Propylene Oxide (HS-GC) ≤5 ppm
Formaldehyde ≤15 ppm
Other Residual Solvents (ICH (03C)) Excluded by Manufacturing Process
Ash (600 °C) ≤0.4%
Water (According to Karl Fischer) ≤1.0%
Bacterial Endotoxins ≤2.5 I.U./g
Microbiological Test (Total Aerobic Microbial Count (TAMC)) ≤10² CFU/g
Microbiological Test (Total Yeast and Mould Count (TYMC)) ≤10 CFU/g
Elemental impurity specifications have been set considering ICH 030 (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH 030 option 1 limit, unless specified and indicated (*).
Corresponds to Ph. Eur., NF.

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