Triethanolamin 99.0-103.0% (by acidimetry) suitable for use as excipient, SAFC®

Leverandør: MERCK PRODUCTION CHEMICALS
Ratings: Ingen bedømmelse

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Synonymer: Tris-(2-hydroxyethyl)amine, 2,2',2''-Nitrilotriethanol

1.08372.1000 1.08372.6025 1.08372.6180
1.08372.1000EA 3770 DKK
1.08372.1000 1.08372.6025 1.08372.6180
Triethanolamin 99.0-103.0% (by acidimetry) suitable for use as excipient, SAFC®
Triethanolamin
Formel: C₆H₁₅NO₃
Molekylvægt: 149.19 g/mol
Kogepunkt: 335.4
Smeltepunkt: 21.6
Massefylde: 1.13 g/cm³ (20 °C)
Flammepunkt: 179 °C (closed cup)
Opbevaringstemperatur: Stue temperatur
MDL Number: MFCD00002855
CAS-nummer: 102-71-6
EINECS: 203-049-8
Merck Index: 13,09739
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Specifikationer Testresultater

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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