Poloxamer 188 stabilised, EMPROVE® EXPERT Ph. Eur., NF

Leverantör: MERCK PRODUCTION CHEMICALS

Synonyms: PEG-PPG-PEG, Kolliphor® P 188, Synperonic® F68, Lutrol® F68, Pluronic® F-68

Stabilization: Stabilised med BHT/Ionol 70 ppm

1.37112.1000 1.37112.9010 1.37112.9025 1.37112.0001
1.37112.1000EA 8025 SEK
1.37112.1000 1.37112.9010 1.37112.9025 1.37112.0001
Poloxamer 188 stabilised, EMPROVE® EXPERT Ph. Eur., NF
Poloxamer 188 (Lutrol® F68, Pluronic® F-68, Synperonic® F68)
Formel: HO(C₂H₄O)a(C₃H₆O)b(C₂H₄O)a
MW: 8400 g/mol
Smältpunkt: 52 °C
Densitet: 1,06 g/cm³ (70 °C)
Flampunkt: 260 °C
Storage Temperature: Omgivande
MDL Number: MFCD00082049
CAS nummer: 9003-11-6

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Specifikation testresultat

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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