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Intended For Use As An Excipient 

• BIS-TRIS HCl, is the chlorinated version of BIS-TRIS, a zwitterionic biological buffer often used in biological pharmaceutical manufacturing for extraction, separation and purification, as well as an intermediate in synthetic reactions and as a process aid in peptide synthesis.

General Product Description:

• Bis-Tris HCl is produced at our cGMP platform in India and then shipped to our Bangor, PA facility where it is tested and repackaged under cGMP conditions.

• Bis-Tris HCl is a White Crystalline product.

• Molecular Formula: C8H19NO5 • HCl

• Molecular Weight: 245.70 g/mol

• CAS Number: 124763-51-5

• There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

• Biospectra certifies that all Bis-Tris HCl BTHY-4250 manufactured at our cGMP platform in India and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts. Bis-Tris HCl manufactured at BioSpectra and any raw materials used in the manufacture of Bis-Tris HCl at BioSpectra are not subject to genetic modification.

• Synonyms: 2,2-Bis(hydroxymethyl)-2, 2’,2”- nitrilotriethanol, BIS-TRIS hydrochloride, Bis(2- hydroxyethyl) aminotris(hydroxymethyl) methane, 2-Bis(2-hydroxyethyl) amino-2-(hydroxymethyl)-1, 3- propanediol

GMP Compliance:

• Bio Pharma Grade Bis-Tris HCl BTHY-4250 is suitable for use as an excipient. It is manufactured in accordance with the IPEC-PQG Joint Good Manufacturing Practice Guide For Excipients. This grade of Bis-Tris HCl is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

Retest Date:

• The recommended retest period for Bis-Tris HCl is two years from the date of manufacture.

Storage and Shipping Conditions:

• Keep container tightly closed in a dry and well-ventilated place.

Package Sizes:

• 10kg, 25 kg and 50 kg pails.

Country of Origin:

• India

  This product is then repacked and retested under cGMP at our Bangor USA cGMP FDA Regulated Facility.

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