Tris / Tromethamine USP, EP, IPEC GMP

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GMP Process Chemical

IPEC GMP Manufactured Product

Tris / Tromethamine

USP, EP, BET*, GMP

Product Code: TRIS-4252

*Bioburden and Endotoxin Tested

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Product Code: TRIS-4252

Suitable for use in biological and biotech chemical process applications from R&D through scale cGMP production.

Tris / Tromethamine is commonly used as a buffer and excipient in downstream biological applications during 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.

CAS #: 77-86-1
Formula: NH₂C(CH₂OH)₃
F.W.: 121.14 g/mol

Product Specifications

Analysis

Specifications

Appearance and Color

White Crystalline Powder

Appearance of Solution (EP)

Passes Test

Assay, Dried Basis (USP/EP)

99.0 - 100.5%

Chloride (EP)

< = 100 ppm

Endotoxin

< = 2.5 EU/g

Identification, IR (USP-A/EP-C)

Conforms to Reference Standard

Identification A (EP), pH (5%) (USP/EP)

10.0 - 11.5

Identification B (USP)

Passes Test

Identification B (EP), Melting Range (USP)

168 - 172°C

Identification C (USP)

Passes Test

Identification D (EP)

Conforms to Reference Standard

Insoluble Matter

< = 0.005%

Loss on Drying (USP/EP)

< = 0.5%

Microbial Content

TAMC

TYMC

< 50 CFU/g

Related Substances (EP)

< = 1.0%

Residue on Ignition / Sulfated Ash (USP/EP)

< = 0.1%

Solubility (40%)

Passes Test

Trace Metals

Iron (Fe) (EP)
Lead (Pb)

< = 5 ppm

Water, KF

< = 0.3%

Printable Version

Key Product Features:

The manufacturing of Tris/Tromethamine, TRIS-4252, is performed at BioSpectra's Stroudsburg, PA facility.
Appears as a white crystalline product
Manufactured in an enzyme free, hormone free, and animal free environment
Contains no known major food allergens (as defined by FDA and WHO)
The final product and its raw materials are not derived from nor come into contact with animal parts, animal products, and/or animal byproducts or derivatives.
Is not subject to genetic modification
Synonyms: Tris(hydroxymethyl) aminomethane; Trometamol; THAM; Trisaminol

Shelf-Life Policy:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Storage & Shipping:

Refer to SDS

Package Sizes:

10kg, 25kg, and 50kg

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.