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GMP Biotech Product

BIS-TRIS BIOTECH

LBLE*, GMP

*Low Bioburden, Low Endotoxin

COAs Spec Sheet

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Product Code: BTRI-4250
Intended for Use in Biopharmaceutical & Biotechnological Applications and Products

Intended to be used as a high purity, GMP Reagent Grade. 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.

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
Enzymes

DNase

Protease

RNase

None Detected

None Detected

None Detected

Trace Metals

Aluminum (Al)

Calcium (Ca)

Lead (Pb)

Phosphorus (P)

≤ 5 ppm

≤ 500 ppm

≤ 10 ppm

≤ 500 ppm

Appearance and Color

 

White Crystalline Powder

Assay (Titration, Dry Basis)

 

99.0% - 101.0%

Bioburden

TAMC

TYMC

≤ 100 CFU/g

≤ 100 CFU/g

Chloride

< 0.005%

Endotoxin

 ≤ 50 EU/g
Absorbance (0.1M)

280nm

340nm

≤ 0.04 a.u.

≤ 0.02 a.u.

Heavy Metals (Pb)

 

≤ 3ppm

Identification (IR)

 

Conforms to Reference Standard

Iron

 

≤ 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

 Clear & Complete

Water (KF)

 ≤ 1.0%

Ammonia (NH4)

≤ 0.5%

Sulfate (SO4)

≤ 0.05%

≤ 0.05%

 

Printable Version

General Product Description:

Molecular Formula: C8H19NO5
Molecular Weight: 209.24 g/mol
CAS Number: 6976-37-0

BIS-TRIS Biotech:

  • Appears as a white crystalline product.
  • Is manufactured under an ICH-Q7 Quality Managed cGMP System
  • Manufactured in an enzyme free, hormone free and animal free environment
  • Has 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:

Three-year expiry from the date of manufacture.

Storage and Shipping Conditions:

Please refer to the SDS for storage and shipping conditions.

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.