Product Category


ICH-Q7 GMP Manufactured Product

BIS-TRIS, LBLE, GMP Excipient Grade

Low Bioburden, Low Endotoxin, Multicompendial, GMP Manufactured

Product Code: BTRI-3250

Intended For Use As An Excipient

BIS-TRIS is a zwitterionic biological “Goods” buffer often used in biological pharmaceutical manufacturing and biochemistry for extraction, separation and purification, as well as an intermediate in synthetic reactions for both proteins and nucleic acid. BIS-TRIS is also used as a process aid in peptide synthesis. It can also be used as a scavenger agent for metal ions such as Cu and Pb.

Product Specifications



Absorbance (0.1M)



≤ 0.04 a.u.

≤ 0.02 a.u.

Appearance and Color  

White Crystalline Powder

Assay (Titration, Dry Basis)


99.0% - 101.0%


≤ 100 CFU/g


< 0.005%


 ≤ 50 EU/g


None Detected
None Detected
None Detected

Heavy Metals (Pb)


≤ 3ppm

Identification (IR) (USP/EP)


Conforms to Reference Standard



≤ 3ppm

Loss on Drying (LOD)


≤ 1.0%

Melting Point

100 – 105°C 

pH (1% aqueous)

8.8 – 9.8 

pKa @ 25°C

6.3 – 6.7 

Residue on Ignition (ROI)

≤ 0.1%

Solubility 0.1M in H2O (USP)

 Clear + complete

Water (KF)

 ≤ 1.0%

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General Product Description:

  • The manufacturing of BIS-TRIS, BTRI-3250 is performed at BioSpectra’s Bangor, PA facility and is conducted in a multi-use processing area using only multi-use equipment.

  • BIS-TRIS is a White Crystalline product

  • Molecular Formula: C8H19NO5

  • Molecular Weight: 209.24 g/mol

  • CAS Number: 6976-37-0

  • 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 BTRI-3250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts. BIS-TRIS manufactured at BioSpectra and any raw materials used in the manufacture of BIS-TRIS at BioSpectra are not subject to genetic modification.

  • Synonyms: 2,2-Bis(hydroxymethyl)-2,2’,2’’- nitrilotriethanol; Bis(2-hydroxyethyl) aminotris(hydroxymethyl)methane


GMP Compliance:

Bio Excipient Grade BIS-TRIS, BTRI-3250 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of BIS-TRIS is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

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.

Retest Date:

The recommended retest period for BIS-TRIS is 18 months from the date of manufacture.

Storage and Shipping Conditions:

Store in a cool, dry place. Store in a cool, dry, well-ventilated area away from incompatible substances. Keep away from acids. Keep containers tightly closed.

Package Sizes:

10kg, 25 kg and 50 kg pails.

Additional Packaging Information