Intended For Use As An Active Pharmaceutical Ingredient 

• Bio Active LBLE Grade of Tromethamine is intended to be used in parenteral drug formulations as an Active Pharmaceutical Ingredient. This product is not to be considered sterile and requires further terminal sterilization.

General Product Description:

• The manufacturing of LBLE API Grade Tromethamine TRIS-2255 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of LBLE API Grade Tromethamine TRIS-2255 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
• 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-2255 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:

• LBLE API Grade Tromethamine TRIS-2255 is suitable for use as a non-Sterile Active Pharmaceutical Ingredient manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide.

Retest Date:

• The recommended retest period for Tromethamine is two years from the date of manufacture.

Storage and Shipping Conditions:

• Store in a clean and dry area.
• Store in the original container.

Package Sizes:

• 10kg, 25kg and 50kg pails.