Tris / Tromethamine USP, EP, JPC, ChP, BET*

BioBuffer Solution Brand Product - TEMPORARILY UNAVAILABLE, Please Inquire for Lead Time.

Process Chemical

ISO Certified

Tris / Tromethamine

USP, EP, JPC, ChP, BET*

Product Code: TRIS-6251

*Bioburden and Endotoxin Tested

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Product Code: TRIS-6251

Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and biological/biotech 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

Absorbance (10%)

260 nm

280 nm

430 nm

< = 0.03 a.u.

< = 0.02 a.u.

< = 0.004 a.u.

Absorbance (40%)

280 nm

290 nm

400 nm

< = 0.06 a.u.

< = 0.2 a.u.

< = 0.02 a.u.

Absorbance (1M)

260 nm

280 nm

430 nm

< = 0.06 a.u.

< = 0.05 a.u.

< = 0.1 a.u.

APHA Color, 20% Aqueous Solution

< = 20 APHA

Appearance of Solution

Passes Test

Assay, Dried Basis

99.0 - 100.5%

Assay, Dried Basis (UltraPure)

> = 99.9%

Chloride

< = 100 ppm

Clarity & Color of Solution

Passes Test

Endotoxin

< = 2.5 EU/g

Foreign Materials, 10% Solution

Clear and Complete

Identification A (JPC)

Passes Test

Identification A (EP), pH (5%)

10.0 - 11.5

Identification, IR (USP-A/EP-C/ChP-3)

Conforms to Reference Standard

Identification B (USP/ChP-1)

Passes Test

Identification B (JPC)

Passes Test

Identification B (EP), Melting Point

168 - 172°C

Identification C (USP)

Passes Test

Identification D (EP/ChP-2)

Conforms to Reference Standard

Insoluble Matter

< = 0.005%

Loss on Drying

< = 0.3%

Microbial Content

TAMC
TYMC

< 50 CFU/g

Non-Volatile Residue

< = 0.1%

Odor

Pass

pH (1 in 100)

10.3 - 10.7

Related Substances

< = 0.10%

Residual Solvents

Pass

Residue on Ignition / Sulfated Ash

< = 0.05%

Solubility (40%)

Pass

Volatile Residue

< = 0.5%

Trace Metals

Arsenic (As)

Barium (Ba)

Bismuth (Bi)

Cadmium (Cd)

Calcium (Ca)

Chromium (Cr)

Cobalt (Co)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Magnesium (Mg)

Manganese (Mn)

Molybdenum (Mo)

Nickel (Ni)

Potassium (K)

Zinc (Zn)

< = 1.6 ppm

< = 5 ppm

< = 1 ppm

< = 5 ppm

< = 1 ppm

< = 5 ppm

< = 1 ppm

< = 5 ppm

< = 50 ppm

< = 5 ppm

Water, KF

< = 0.2%

Key Product Features:

Appears as a white crystalline product
Manufactured in accordance with the ISO Certified Quality Management System
Manufactured in an enzyme free, hormone free and animal free environment
Contains no 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 (Hydroxyethyl) Aminomethane; Trisaminol; Trismethylolaminomethane; 2-Amino-2(Hydroxymethyl) propane-1,2-diol

Shelf-Life Policy:

Please inquire for information regarding shelf life.

Storage & Shipping:

Refer to SDS.

Package Sizes:

1kg, 5kg, 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.