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GMP Biotech Product

TRIS HCL BIOTECH

HIGH ASSAY, LBLE*, GMP

*Low Bioburden, Low Endotoxin

COAs Spec Sheet

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Product Code: THCL-4251
Intended for Use in Biopharmaceutical & Biotechnological Applications and Products

As an ultra- high purity, GMP Reagent Grade of Tris hydrochloride suitable for critical applications where high assay is required. Tris Hydrochloride is considered a “Good’s” buffer because it has a low UV absorptivity, minimum reactivity, stable pH and is highly soluble in water.

Formula: C4H11NO3 · HCl
F.W.: 157.60 g/mol.
CAS #: 1185-53-1

Product Specifications

ANALYSIS

SPECIFICATIONS

Trace Metals

Arsenic (As)

Calcium (Ca)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Magnesium (Mg)

Manganese (Mn)

Zinc (Zn)

≤ 5 ppm

≤ 1 ppm

≤ 1 ppm

≤ 1 ppm

≤ 1 ppm

≤ 5 ppm

≤ 1 ppm

≤ 1 ppm

Enzymes

DNase

RNase

Protease 

None

None

None

Absorbance (1M)

260nm

280nm

400nm

≤ 0.06 a.u.

≤ 0.06 a.u.

≤ 0.01 a.u.

Appearance  
White, Crystalline Powder to Needle-Like Crystals
Assay, Dried  
≥ 99.0%
Bioburden  
≤ 100 CFU/g
Endotoxin  
≤ 2.5 EU/g
Identification

(IR)

(Chloride)

Passes Test

Passes Test

Insoluble  
< 0.005%
Loss on Drying @ 105°C ≤ 0.5%
Melting Range  
147 – 152ºC
pH

(1% Aqueous Solution)

(0.5M) @ 25°C

4.0 – 5.0

3.5 – 5.0

Water
 
≤ 1.0%

 

Printable Version

General Product Description:

  • Molecular Formula: C4H11NO3 · HCl
  • Molecular Weight: 157.60 g/mol
  • CAS Number: 1185-53-1

Tris Hydrochloride Biotech:

  • Appears as a white crystalline product.
  • Is manufactured under an ICH-Q7 Quality Managed cGMP System
  • Manufactured in an enzyme free, hormone free and animal free environment
  • Has no known major food allergens (as defined by FDA and WHO)
  • The final product nor 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: Tris Hydrochloride (HCl), 2-Amino-2-(Hydroxymethyl)-1,3-Propanediol Hydrochloride, Tris (Hydroxymethyl) Aminomethane Hydrochloride

Shelf Life Policy:

Three-year expiry from the date of manufacture.

Storage and Shipping Conditions:

Please refer to the SDS for storage and shipping conditions.

Package Size:

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.