Product Category

Reagent / Compendial

ICH-Q7 GMP Manufactured Product

TRIS Hydrochloride (HCL)
99.9% High Purity, LBLE, LEI, Reagent GMP Grade

Low Bioburden, Low Endotoxin, Multicompendial, GMP Manufactured,
Reagent Grade Product

Product Code: THCL-3257 | Previously: TH3257

Intended For Use As A High Purity Reagent Grade

For Critical Analytical, Diagnostic and Pharmaceutical Applications, and downstream manufacture of drug products where a high purity, high assay, GMP Tris Hydrochloride is required. Tris Hydrochloride is a considered a “Good’s” buffer because it has low UV absorptivity, minimum reactivity, stable pH and is soluble in water.

Product Specifications



Absorbance (1M)




≤ 0.06 a.u.

≤ 0.06 a.u.

≤ 0.01 a.u.

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










Passes Test

Passes Test

< 0.005%
Loss on Drying @ 105°C  
≤ 0.5%
Melting Range  

(1% Aqueous Solution)

(0.5M) @ 25°C

4.0 - 5.0

3.5 - 5.0

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


≤ 1.0%

Printable Version

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General Product Description:

  • The manufacturing of Tris Hydrochloride THCL-3257 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
  • Tris Hydrochloride (HCl) Buffer is a White Crystalline product
  • Molecular Formula: C4H11NO3 • HCI
  • Molecular Weight: 157.60 g/mol.
  • CAS Number: 1185-53-1
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
  • BioSpectra certifies that all Tris Hydrochloride (HCl) Buffer THCL-3257 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
  • Tris Hydrochloride (HCl) Buffer manufactured at BioSpectra and any raw materials used in the manufacture of Tris Hydrochloride at BioSpectra are not subject to genetic modification.
  • Synonyms: Tris Hydrochloride (HCl), 2-Amino-2-(Hydroxymethyl)- 1,3-Propanediol Hydrochloride; Tris (Hydroxymethyl) Aminomethane Hydrochloride


Product Statements:

Plant or Animal Origin Statement: BioSpectra certifies that Tris, Product Code THCL-3257, manufactured by BioSpectra is of Synthetic origin. BioSpectra certifies that Tris, Product Code THCL-3257, is not derived from Plant or Animal Origin.

Metal Residue Statement: BioSpectra certifies that Tris, Product Code THCL-3257, manufactured by BioSpectra is manufactured without the use of metal catalysts and metal reagents. There are no known risks to metal residues in this product.

Melamine Statement: Based on the manufacturing process and the controlled handling, storage, and analysis of Tris, Product Code THCL-3257, BioSpectra certifies that there is low risk for melamine contamination. Additionally, when tested for melamine, this product reports less than 0.15 ppm.

Residual Solvents Statement: Based on the manufacturing process and the controlled handling, storage and analysis of this product, this product complies with the requirements and specifications listed in the current USP method <467> Tables 1, 2, 3, or 4.

GMP Compliance:

Bio Excipient Grade Tris Hydrochloride THCL-3257 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tris Hydrochloride is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


The recommended expiration period for Tromethamine Hydrochloride is three years from the date of manufacture..

Storage and Shipping Conditions:

Ship and store in ambient temperature. Store in a clean and dry area. Store in the original container.

Package Sizes:

10kg, 25kg and 50kg drums.

Additional Packaging Information

COAs and Tech Docs


THCL-3257 | TH3257

CAS #: 1185-53-1

Formula: C4H11NO3·HCl

Sol. In H2O (g/L): 1,010

F.W.: 157.60 g/mol

pH @ 20°C: 4.5 - 6.0

Useful pH: 7.0-9.0

pKa @ 20˚C: 8.2