Intended For Use As An Excipient 

• Tromethamine (Tris), is commonly used as a buffer and excipient in biological applications downstream in the manufacture of drug products. Tris 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-3251 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-3251 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

GMP Compliance:

• Bio Excipient Grade Tromethamine, Chinese Pharmacopeia TRIS-3251 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tromethamine, Chinese Pharmacopeia 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:

• 10kg, 25kg and 50kg pails.

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.