Tris HCl, BET, LEI, GMP, Excipient

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Excipient

ICH Q7 GMP Manufactured Product

TRIS Hydrochloride

BET*, LEI**, GMP, Excipient
Product Code: THCL-3259

*Bioburden and Endotoxin Tested, **Low Elemental Impurities

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Product Code: THCL-3259

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

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.

CAS #: 1185-53-1
Formula: NH₂C(CH₂OH)₃· HCl
F.W.: 157.60 g/mol
Solubility in H₂O: 101 g/100mL
pH (0.5M): 3.5 - 5.0
pK_a: 8.0 - 8.4

Product Specifications

ANALYSIS

SPECIFICATIONS

Absorbance (1M)

260nm

280nm

400nm

< = 0.06 a.u.

< = 0.05 a.u.

< = 0.01 a.u.

Appearance and Color

White Crystals

Assay, Dried Basis

99.5% - 101.0%

Microbial Content

TAMC

TYMC

< 50 CFU/g

Endotoxin

< = 2.5 EU/g

Enzymes

DNase

RNase

Protease

None Detected

Identification, IR

Conforms to Reference Standard

Identification, Chloride

Passes Test

Insoluble Matter

< = 0.001%

Loss on Drying

< = 0.5%

Melting Range

150 – 152ºC

pH (0.5M)

3.5 - 5.0

pH (1%)

4.0 - 5.0

pK_a

8.0 – 8.4

Residue on Ignition

< = 0.03%

Solubility (35%)

Passes Test

Trace Metals

Arsenic (As)

Cadmium (Cd)

Calcium (Ca)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Manganese (Mn)

Magnesium (Mg)

Zinc (Zn)

< = 1 ppm

Water, KF

< = 0.5%

Key Product Features:

The manufacturing of Tris Hydrochloride, THCL-3259 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: 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:

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.