trietanoloamina 99.0-103.0% (by acidimetry) suitable for use as excipient, SAFC®
Dostawca: MERCK PRODUCTION CHEMICALS
Synonim:
Tris-(2-hydroxyethyl)amine, 2,2',2''-Nitrilotriethanol
1.08372.1000
1.08372.6025
1.08372.6180
1.08372.1000EA
0
PLN
1.08372.1000
1.08372.6025
1.08372.6180
trietanoloamina 99.0-103.0% (by acidimetry) suitable for use as excipient, SAFC®
trietanoloamina
Formuła:
C₆H₁₅NO₃ MW: 149.19 g/mol Temp. Wrzenia: 335.4 Temp. topnienia: 21.6 Gęstość: 1.13 g/cm³ (20 °C) Temp. Zapłonu: 179 °C (zamknięty kubek) Temperatura przechowywania: Temperatura otoczenia |
Numer MDL:
MFCD00002855 Numer CAS: 102-71-6 Numer WE (dawny EINECS): 203-049-8 Klasyfikacja Merck : 13,09739 |
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Wyniki testów specyfikacyjnych
Assay (acidimetric, calc. on anhydrous substance) | 99.0 - 103.0 % |
Identity (IR-spectrum) | passes test |
Identity (GC) | conforms |
Appearance | colorless to slightly yellow viscose liquid |
Appearance of solution | Clear and not more intense in colour than reference solution B₆ |
Clarity of solution | passes test |
PH (1.0 g in 10 ml water) | 10.5 - 11.5 |
Refractive index (n 20/D) | 1.482 - 1.485 |
Relative Density (d 20/20) | 1.120 - 1.130 |
Relative Density (d 25/25) | 1.120 - 1.128 |
Heavy metals (as Pb) | ≤ 0.0010 % |
As (Arsenic) | ≤ 0.000075 % |
Fe (Iron) | ≤ 0.0005 % |
Related substances (Ethanolamine, GC) | ≤ 0.1 % |
Related substances (Diethanolamine, GC) | ≤ 0.5 % |
Related substances (total impurity, GC) | ≤ 1.0 % |
Related substances (N-Nitrosodiethanolamine, GC) | ≤ 24 ppb |
Residual solvents (ICH Q3C) | ...excluded by production process |
Sulfated ash (600 °C) | ≤ 0.05 % |
Water (according to Karl Fischer) | ≤ 0.5 % |
Endotoxins | ≤ 2.5 I.U./ml |
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). | |
N-Nitrosodiethanolamine (GC) test performed by a qualified external laboratory. | |
Meets analytical specifications of Ph Eur, JPE, NF. | |
The information provided does not imply the suitability of the product for pharmaceutical applications. It is customer's sole responsibility, prior to use, to determine that the product is suitable and permitted for the customer's intended use and application. |
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