TROMETHAMINE (TRIS)

Product Specifications

ANALYSIS	SPECIFICATIONS
Appearance and Color	White / Crystals
Appearance of Solution	Clear and Colorless
Assay, Dried Substance	99.0-100.5%
Bacterial Endotoxins	≤ 3.0 EU/g
Chlorides	≤100ppm
Identification A, pH	10.0-11.5
Identification B, Melting Point	168-174 ºC
Identification C, IR	Conforms to Reference Standard
Identification D	Conforms to Reference Standard
Iron	≤10ppm
Loss on Drying	≤0.5%
pH 5%	10.0 – 11.5
Related Substances	≤1.0%
Sulfated Ash	≤0.1%

General Product Description:

The manufacturing of LBLE API Grade Tromethamine TRIS-2257 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-2257 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-2257 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.

Bulk GMP Fine Chemicals exclusively manufactured in North America

American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.