General Product Description:
- The manufacturing of Tromethamine TRIS-3255 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
- Tromethamine is a White Crystalline product
- Molecular Formula: C4H11NO3
- Molecular Weight: 121.14 g/mol.
- CAS Number: 77-86-1
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all Tromethamine TRIS-3255 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts. Tromethamine manufactured at BioSpectra and any raw materials used in the manufacture of Tromethamine at BioSpectra are not subject to genetic modification.
- Synonyms: Tris, Tromethamine, Tris(hydroxymethyl)aminomethane
Plant or Animal Origin Statement: BioSpectra certifies that Tris, Product Code TRIS-3255, manufactured by BioSpectra is of Synthetic origin. BioSpectra certifies that Tris, Product Code TRIS-3255, is not derived from Plant or Animal Origin.
Metal Residue Statement: BioSpectra certifies that Tris, Product Code TRIS-3255, manufactured by BioSpectra is manufactured without the use of metal catalysts and metal reagents. There are no known risks to metal residues in this product.
Melamine Statement: Based on the manufacturing process and the controlled handling, storage, and analysis of Tris, Product Code
TRIS-3255, BioSpectra certifies that there is low risk for melamine contamination. Additionally, when tested for melamine, this product reports less than 0.15 ppm.
Residual Solvents Statement: Based on the manufacturing process and the controlled handling, storage and analysis of this product, this product complies with the requirements and specifications listed in the current USP method <467> Tables 1, 2, 3, or 4.
Bio Excipient Grade Tromethamine Multicompendial TRIS-3255 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tromethamine Multicompendial is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
The recommended retest period for Tromethamine is two years from the date of manufacture.
Storage and Shipping Conditions:
Store in a cool, dry place. Store in a cool, dry, well-ventilated area away from incompatible substances. Keep away from acids. Keep containers tightly closed.
10 kg and 25 kg pails and 50 kg drums