Tris, USP, EP, GMP, Excipient

Excipient

ICH Q7 GMP Manufactured Product

Tris

USP, EP, BET*, GMP, Excipient
Product Code: TRIS-3254

*Bioburden and Endotoxin Tested

Minimum Order Quantity: 500kg
Lead Time (if no stock): 3-months

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Product Code: TRIS-3254

Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.

Tromethamine (Tris) 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
Solubility at 25˚C: 550 mg/mL
pH (5% aq. Solution): 10.0 - 11.5
pK_a at 25˚C: 8.07

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance and Color

White Crystals

Appearance of Solution (EP)

Passes Test

Assay, Dried Basis (USP/EP)

99.0 – 100.5%

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 C (USP)

Passes Test

Identification D (EP)

Conforms to Reference Standard

Iron (Fe) (EP)

< = 10 ppm

Loss on Drying (USP/EP)

< = 0.5%

Microbial Content

TAMC

TYMC

< = 500 CFU/g

< = 200 CFU/g

Related Substances (EP)

< = 1.0%

Residue on Ignition / Sulfated Ash (USP/EP)

< = 0.1%

Printable Version

Key Product Features:

The manufacturing of Tris, TRIS-3254 is performed at BioSpectra’s Stroudsburg, PA facility.
Appears as white crystals
Manufactured in accordance with ICH Q7
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: Trometamol; THAM; Tris (Hydroxymethyl) Aminomethane; Trisaminol; Trismethylolaminomethane; 2- Amino-2 (Hydroxymethyl) propane-1,3-diol; Tromethamine

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 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.