Tris HCl Biotech, High Assay, GMP

GMP Biotech Product

TRIS HCL BIOTECH

High Assay, LBLE*, GMP
Product Code: THCL-4251

*Low Bioburden, Low Endotoxin

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Product Code: THCL-4251

Suitable for use in biological and biotech chemical process applications from R&D through scale cGMP production.

This product is suitable for critical applications where high assay, GMP material is required. Tris Hydrochloride is considered a Good’s buffer because it has a low UV absorptivity, minimum reactivity, stable pH and it is highly soluble in water.

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

Product Specifications

ANALYSIS

SPECIFICATIONS

Absorbance (1M)

260 nm

280 nm

400 nm

< = 0.06 a.u.

< = 0.01 a.u.

Appearance and Color

White Crystalline Powder to Needle-Like Crystals

Assay, Dried Basis

> = 99.0%

Microbial Content

TAMC

TYMC

< 50 CFU/g

Endotoxin

< = 2.5 EU/g

Enzymes

DNase

RNase

Protease

None Detected

Identification, Chloride

Passes Test

Identification, IR

Conforms to Reference Standard

Insoluble Matter

< = 0.005%

Loss on Drying

< = 0.5%

Melting Range

147 – 152ºC

pH (0.5M)

3.5 - 5.0

pH (1%)

4.0 - 5.0

Trace Metals

Arsenic (As)

Calcium (Ca)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Magnesium (Mg)

Manganese (Mn)

Zinc (Zn)

< = 5 ppm

< = 1 ppm

< = 5 ppm

< = 1 ppm

Water, KF

< = 1.0%

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:

100g, 500g, 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.