TRIS AMINO™ AC (Advanced Crystal) Ultra Pure is manufactured exclusively by Advancion using proprietary process technology and is less prone to clumping and hardness – without any change to the molecule itself. TRIS AMINO AC Ultra Pure has a unique crystal morphology with a larger, more rounded particle structure and does not typically form strong cakes even when subjected to elevated conditions that tend to contribute to clumping – a chronic industry problem when using traditional TRIS buffers, especially at larger scales.
Similar to TRIS AMINO™ Ultra Pure, Advancion manufactures TRIS AMINO AC Ultra Pure to the highest purity levels under cGMP for use as a raw material in highly regulated environments. We offer multicompendial grades of TRIS AMINO AC 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.
Learn MORE about why clumping happens, and how the next-generation TRIS AMINO™ AC Advanced Crystals can provide critical operational benefits when it comes to handling and preparation.
- 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.
Clumping during transport and storage is a well-known and challenging characteristic of conventional TRIS buffer products. To address this long-standing industry challenge, Advancion developed the next generation TRIS AMINO™ AC Advanced Crystals, produced in our newly expanded, state-of-the art manufacturing facility in Ibbenbüren, Germany.
- Unique morphology reduces caking, making it less prone to clumping and hardness
- Low interparticle cohesion between crystals requires less energy to break up clumps if and when they do form
- More spherical crystals allow for improvements in dispensing and transport through conveyors
- Lower dust emissions due to fewer fine particles
- No additives or anti-clumping agents
- Highest purity and testing requirements
- cGMP compliant with comprehensive validation documentation
- 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
Produced in Germany under quality systems that include: ISO 9001:2015, IPEC, cGMP and select ICH principles
FDA Approval as an inactive ingredient in approved drug products
Listed on EPA inert ingredient database for non-food use
USP, EP, JPC, ChP Monograph Compliant
IPEC Guidelines Compliance
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