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Safety Information

1.08307

SAFC

Tris(hydroxymethyl)aminomethane

(Trometamol) high purity, EMPROVE® EXPERT, Ph. Eur., BP, ChP, JPC, USP

Pharma Manufacturing

Synonym(s):

Aminomethylidine trimethanol, 2-Amino-2-hydroxymethyl-1.3-propanediol, TRIS-buffer, Tromethamine, Tris(Hydroxymethyl)aminomethane, 2-Amino-2-(hydroxymethyl)-1,3-propanediol, THAM, Tris base, Trometamol

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About This Item

Linear Formula:
NH2C(CH2OH)3
CAS Number:
Molecular Weight:
121.14
Beilstein:
741883
MDL number:
UNSPSC Code:
12352209
EC Index Number:
201-064-4

Agency

BP
ChP
JPC
Ph. Eur.
USP

Quality Level

vapor pressure

0.0267 hPa ( 20 °C)

description

EMPROVE® EXPERT Ph Eur,BP,JPC,USP,ACS

product line

EMPROVE® EXPERT

form

solid

feature

RNase and DNase free

pH

10.2-10.6 (20 °C, 6 g/L in H2O)

useful pH range

7-9

pKa (25 °C)

8.1

bp

219-220 °C/10 mmHg (lit.)
219-220 °C/13.3 hPa

mp

167-172 °C (lit.)

density

1.35 g/cm3 at 23 °C

application(s)

liquid formulation
pharmaceutical
semi-solid formulation

storage temp.

no temp limit

SMILES string

NC(CO)(CO)CO

InChI

1S/C4H11NO3/c5-4(1-6,2-7)3-8/h6-8H,1-3,5H2

InChI key

LENZDBCJOHFCAS-UHFFFAOYSA-N

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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

Tris(hydroxymethyl)aminomethane (Trometamol) is a commonly used buffer component in biomolecule downstream chromatography steps as well as final liquid formulation.
Due to its low polyoxymethylene limits, Tris(hydroxymethyl)aminomethane (Trometamol) Emprove® Expert is suitable for use at elevated concentrations without risking precipitation. Also, low microbial and endotoxin limits facilitate the use of this product in high-risk applications.

Legal Information

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

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

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Articles

This overview describes the challenges when developing parenteral formulations and strategies to overcome them and reduce the risk of production.

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