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1.37044 SAFC

Ethanolamine

EMPROVE® Expert, Ph. Eur., BP, NF

Synonym: 2-Aminoethanol, Monoethanolamine, Ethanolamine

  • CAS Number 141-43-5

  • Empirical Formula (Hill Notation) C2H7NO

  • Molecular Weight 61.08

  •  MDL number MFCD00008183

  •  EC Index Number 205-483-3

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Properties

Related Categories Biopharmaceutical Manufacturing, Biopharmaceutical Process Development and Manufacturing, Cell Culture Ingredients and Supplements for Biopharmaceutical Manufacturing More...
Agency/Method   BP
  NF
  Ph. Eur.
Quality Level   500
vapor pressure   0.5 hPa ( 20 °C)
product line   EMPROVE® Expert
assay   98.0-100.5% (acidimetric)
form   liquid
autoignition temp.   410 °C
potency   1515 mg/kg LD50, oral (Rat)
  1025 mg/kg LD50, skin (Rabbit)
expl. lim.   3.4-27 % (v/v)
pH   12.1 (20 °C, 100 g/L in H2O)
kinematic viscosity   20 cSt(23 °C)
bp   171 °C/1013 hPa
mp   10.5 °C
transition temp   flash point 92.5 °C
density   1.02 g/cm3 at 20 °C
InChI   1S/C2H7NO/c3-1-2-4/h4H,1-3H2
InChI key   HZAXFHJVJLSVMW-UHFFFAOYSA-N
storage conditions   Store at +15°C to +25°C.

Description

General description

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

Ethanolamine, a primary amine, is typically used as a buffering agent in small molecule liquid formulations. It may also be used in large molecule downstream purification as a chromatography buffer component.
Due to its low microbial and endotoxin limits, Ethanolamine Emprove® EXPERT is especially suitable for high-risk applications.
The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Analysis Note

Assay (acidimetric): 98.0 - 100.5 %
Identity (IR-spectrum): conforms
Appearance: Clear, colorless or pale yellow liquid.
Refractive index (n 20/D): 1.453 - 1.459
Density (d 20/4): 1.014 - 1.017 g/cm³
Specific gravity (d 25/25): 1.013 - 1.016
Weight per mL: 1.014 - 1.023 g
Distilling range (167 °C - 173 °C): ≥ 95
Heavy metals (as Pb): ≤ 0.001 %
Fe (Iron): ≤ 0.00001 %
Related substances (GC) (Diethanolamine): ≤ 0.5 %
Related substances (GC) (Triethanolamine): ≤ 0.5 %
Related substances (GC) (any other impurity): ≤ 0.5 %
Related substances (GC) (Sum of all impurities): ≤ 2.0 %
Residual solvents (ICH Q3C): ...excluded by production process
Residue on ignition (600 °C): ≤ 0.1 %
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 (*).
Min. shelf life: see product label

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety & Documentation

Safety Information

Emprove® Dossiers

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