Tris HCl, High Assay, GMP

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GMP Process Chemical

IPEC GMP Manufactured Product

Tris Hydrochloride

LBLE*, GMP
Product Code: THCL-4251

*Low Bioburden, Low Endotoxin

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Product Code: THCL-4251

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 and Color

White Crystalline

Assay, Dried Basis

> = 99.5%

Assay, by Titration (0.1N NaOH)

99.5 - 101.0%

Chloride

Passes Test

Cytotoxicity

Passes Test

Endotoxin

< = 2.5 EU/g

Enzymes

DNase

RNase

Exonuclease

Protease

None Detected

Identification, IR

Conforms to Reference Standard

Insoluble Matter

< = 0.001%

Loss on Drying

< = 0.5%

Melting Point

149 – 153ºC

Microbial Content

TAMC

TYMC

< 50 CFU/g

pH (1%)

4.2 - 4.9

Residue on Ignition

< = 0.1%

Residual Solvents

Methanol

Nitromethane

Ethanol

Ethyl methyl ketone

< = 300 ppm

< = 50 ppm

< = 5000 ppm

Solubility (1.0M)

Clear, Colorless Solution

Trace Metals

Aluminum (Al)

Arsenic (As)

Barium (Ba)

Bismuth (Bi)

Cadmium (Cd)

Calcium (Ca)

Chromium (Cr)

Cobalt (Co)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Lithium (Li)

Magnesium (Mg)

Manganese (Mn)

Mercury (Hg)

Molybdenum (Mo)

Nickel (Ni)

Potassium (K)

Silver (Ag)

Sodium (Na)

Strontium (Sr)

Tin (Sn)

Zinc (Zn)

< = 5 ppm

< = 1 ppm

< = 5 ppm

< = 1 ppm

< = 5 ppm

< = 1 ppm

< = 5 ppm

< = 50 ppm

< = 5 ppm

< = 50 ppm

< = 5 ppm

Water, KF

< = 0.5%

Printable Version

Key Product Features:

Appears as a white crystalline powder to needle-like crystals
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.