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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.

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.

Expiration:

• 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.