Intended For Use As An Excipient 

• Tromethamine (TRIS BASE), is commonly used as a buffer and excipient in biological applications downstream in the manufacture of drug products. TRIS BASE is considered a “Good’s” buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water.

General Product Description:

• The manufacturing of Tromethamine TRIS BASE TRIS-3255 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
• TRIS BASE 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 TRIS BASE TRIS-3255 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts. TRIS BASE manufactured at BioSpectra and any raw materials used in the manufacture of TRIS BASE at BioSpectra are not subject to genetic modification.
• Synonyms: Tris, Tromethamine, Tris(hydroxymethyl)aminomethane, TRIS BASE

Product Statements:

• Plant or Animal Origin Statement: BioSpectra certifies that TRIS BASE, Product Code TRIS-3255, manufactured by BioSpectra is of Synthetic origin. BioSpectra certifies that TRIS BASE, Product Code TRIS-3255, is not derived from Plant or Animal Origin.

  Metal Residue Statement: BioSpectra certifies that TRIS BASE, 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.

GMP Compliance:

• Bio Excipient Grade Tromethamine (TRIS BASE) 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 (TRIS BASE) Multicompendial is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Expiration:

• The recommended expiration period for Tromethamine is three 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.

Package Sizes:

• 10 kg and 25 kg pails and 50 kg drums