Poloxamer 188 estabilizado, EMPROVE® EXPERT Ph. Eur., NF
Proveedor: MERCK PRODUCTION CHEMICALS
Estabilización:
estabilizado con BHT/Ionol 70 ppm
1.37112.1000
1.37112.9010
1.37112.9025
1.37112.0001
1.37112.1000EA
495
EUR
1.37112.1000
1.37112.9010
1.37112.9025
1.37112.0001
Poloxamer 188 estabilizado, EMPROVE® EXPERT Ph. Eur., NF
Poloxamer 188 (Lutrol® F68, Pluronic® F-68, Synperonic® F68)
Formula:
HO(C₂H₄O)a(C₃H₆O)b(C₂H₄O)a Pto. de fusión: 52 °C Densidad: 1,06 g/cm³ (70 °C) Pto. de inflamación: 260 °C Temperatura de almacenaje: Ambiente |
Número MDL:
MFCD00082049 Núm. CAS: 9003-11-6 |
Resultados test especificaciones
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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