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GMP Biotech Product

BIS-TRIS BIOTECH

LBLE*, GMP
Product Code: BTRI-4250

*Low Bioburden, Low Endotoxin

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Product Code: BTRI-4250
Suitable for use in biological and biotech chemical process applications from R&D through scale cGMP production.

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, or as a scavenger agent for metal ions such as Cu and Pb.

CAS #: 6976-37-0
Formula: C8H19NO5
pH @ 25°C: 6.3 - 6.7
Melting Point/Range: 100 - 105°C
F.W.: 209.24 g/mol

Product Specifications:

Analysis Specifications
Absorbance (0.1M)

280 nm

340 nm

< = 0.04 a.u.

< = 0.02 a.u.

Ammonium

< = 500 ppm

Appearance and Color

 

White Crystalline Powder

Assay, Dried Basis

 

99.0% - 101.0%

Microbial Content

TAMC

TYMC

< = 100 CFU/g

< = 100 CFU/g

Chloride

< = 50 ppm

Endotoxin

 < = 50 EU/g

Enzymes

DNase

Protease

RNase

None Detected

None Detected

None Detected

Identification, IR

 

Conforms to Reference Standard

Loss on Drying

 

< = 1.0%

Melting Point

 

100 – 105°C

pH (1%)

8.8 - 9.8

pKa

6.3 - 6.7

Residue on Ignition

< = 0.1%

Solubility (0.1M)

Clear and Complete

Sulfate

 < = 50 ppm
Trace Metals

Aluminum (Al)

Calcium (Ca)

Iron (Fe)

Lead (Pb)

Phosphorus (P)

< = 5 ppm

< = 500 ppm

< = 3 ppm

< = 3 ppm

< = 500 ppm

Water, KF

< = 1.0%

 

Printable Version

Key Product Features:

  • Appears as a white crystalline powder
  • Manufactured in accordance with IPEC
  • Manufactured in an enzyme free, hormone free and animal free environment
  • Contains 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 byproducts or derivatives.
  • Is not subject to genetic modification
  • Synonyms: 2,2-Bis(hydroxymethyl)-2,2’,2’’- nitrile tri ethanol; Bis(2-hydroxyethyl) amino tris (hydroxymethyl)methane

Shelf-Life Policy:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Storage & Shipping:

Refer to SDS.

Package Sizes:

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.