TRIS AMINO™ Ultra Pure is manufactured to the highest purity levels under cGMP for use as a raw material in highly regulated environments. Advancion offers multicompendial grades of TRIS AMINO Ultra Pure, which are commonly used as an API salt, excipient, and processing buffer for use in the purification of biological molecules. With a mild alkalinity for buffering at physiological pH levels, TRIS AMINO™ AC Ultra Pure offers chemical stabilization in aqueous formulations and exhibits minimal salt effects. Complete quality documentation is available, including validated process controls.
- Pharmaceutical Raw Material Compliant with USP, EP, JPC, and ChP Monographs
- Commercial Purification (Downstream Processing) of Biological Molecules, Including Monoclonal Antibodies and Recombinant Proteins
- Processing Aid for Insulin Manufacturing
- Non-Sterile Pharmaceutical Excipient
- Buffer for Molecular Biology and Clinical Diagnostic Applications
- pH Buffering of Enzymes in Biotechnology Applications
- Small Molecule API Salt to Systematically Adjust Drug Hydrophilicity
- Small Molecule Synthesis Building Block
- Purity 99.9%
- Molecular weight 121.14
- Melting point 168-172°C
- pKa @ 20°C 8.3
- pKa @ 37°C 7.8
- pKa/°C -0.03
- pH of 0.1M aqueous solution (20°C) 10.4
- Δ pH/10X dilution -0.05 to -0.10
*Values shown are typical properties and are not to be considered product specifications. Test methods available upon request.
- Highest purity and testing requirements
- cGMP compliant with comprehensive validation documentation
- Manufactured in the USA
- Produced under quality systems that include: ISO 9001:2015, IPEC, cGMP and select ICH principles
- Proven safe use in commercial drug products
- Fully traceable supply chain with line of sight to the base materials
- Elemental impurity risk assessment using ICP-MS technology
- Can maintain pH from 7 to 9 by utilizing a combination of free base and its salts
- Structure has both amine and alcohol functionality to provide versatile chemical reactivity
- State-of-the-art filling and packaging suites dedicated for Life Sciences products
Broadly registered for use in all major geographies
FDA Approval as an inactive ingredient in approved drug products
China Drug Master file (DMF)
Listed on EPA inert ingredient database for non-food use
USP, EP, JPC, ChP Monograph Compliant
cGMP Manufacturing
IPEC Guidelines Compliance
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