Poloxamer 188 stabilisiert, EMPROVE® EXPERT Ph. Eur., NF
Lieferant: Merck
Synonyme:
Synperonic® F68
, Lutrol® F68
, PEG-PPG-PEG
, Kolliphor® P 188
, Pluronic® F-68
Stabilisierung:
Stabilisiert mit BHT/Ionol/2,6-Di-tert-butyl-4-methylphenol 70 ppm
1.37112.0001EA
0
EUR
1.37112.0001
1.37112.1000
1.37112.9025
1.37112.9010
Poloxamer 188 stabilisiert, EMPROVE® EXPERT Ph. Eur., NF
Kolliphor® P 188 (Lutrol® F68, Pluronic® F-68, Synperonic® F68)
|
Formel:
HO(C₂H₄O)a(C₃H₆O)b(C₂H₄O)a Molecular Weight: 8400 g/mol Schmelzpunkt: 52 °C Dichte: 1,06 g/cm³ (70 °C) Flammpunkt: 260 °C Lagertemperatur: Raumtemperatur |
MDL:
MFCD00082049 CAS-Nummer: 9003-11-6 |
Spezifikation Testergebnisse
| 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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