Tris HCL, IPEC GMP

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GMP Process Chemical

IPEC GMP Manufactured Product

Tris Hydrochloride

BET*, GMP

Product Code: THCL-4250

*Bioburden and Endotoxin Tested

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Product Code: THCL-4250

Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and biological/biotech process applications from R&D through scale cGMP production.

Tris Hydrochloride is a stabilizing buffer in biological applications such as electrochromatography, UV analysis and HPLC. It is used to adjust and stabilize the pH ranges for gels used in electrophoresis applications. Tris Hydrochloride is extensively used as a biological buffer or a component of buffer solutions.

Formula: NH₂C(CH₂OH)₃ · HCl
F.W.: 157.60 g/mol.
CAS #: 1185-53-1

Product Specifications

Analysis

Specifications

Absorbance (1.0M)

260 nm

280 nm

400 nm

< = 0.06 a.u.

< = 0.05 a.u.

< = 0.01 a.u.

Appearance

White Crystalline

Assay, Dried Basis

99.5 - 101.0%

Chloride

Passes Test

Endotoxin

< = 2.5 EU/g

Identification, IR

Conforms to Reference Standard

Loss on Drying

< = 0.5%

Melting Point

150 - 153°C

Microbial Content

TAMC

TYMC

< 50 CFU/g

pH (1%)

4.2 - 5.0

pH (0.5M)

3.5 - 5.0

Residual Solvents

Methanol

Nitromethane

< = 300 ppm

< = 50 ppm

Solubility (1.0M)

Clear, Colorless Solution

Trace Metals

Arsenic (As)

Calcium (Ca)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Magnesium (Mg)

< = 10 ppm

Water, KF

< = 0.5%

Printable Version

Key Product Features:

Appears as a white crystalline powder
Manufactured in accordance with IPEC
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 its raw materials are not derived from nor come into contact with animals, animal parts, animal products, and/or animal by products or derivatives.
Is not subject to genetic modification
Synonyms: 2-Amino-2-(Hydroxymethyl)propane-1,3-diol hydrochloride; Tri(Hydroxymethyl) Aminomethane Hydrochloride

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:

1kg, 5kg, 10kg, 25kg, 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.