BIS-TRIS, GMP, Excipient

Excipient

ICH-Q7 GMP Manufactured Product

BIS-TRIS

LBLE*, GMP, Excipient Grade
Product Code: BTRI-3250

*Low Bioburden, Low Endotoxin

Minimum Order Quantity: 50kg
Lead Time: 1-3 months

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

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.

CAS #: 6976-37-0
Formula: C₈H₁₉NO₅pH @ 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)

280nm

340nm

< = 0.04 a.u.

< = 0.02 a.u.

Appearance and Color

White Crystals

Assay, Dried Basis

99.0% - 101.0%

Microbial Content

TAMC

TYMC

< = 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

pK_a

6.3 – 6.7

Residue on Ignition

< = 0.1%

Solubility (0.1M)

Clear and Complete

Trace Metals

Iron (Fe)

Lead (Pb)

< = 3 ppm

Water, KF

< = 1.0%

Printable Version

General Product Description:

Molecular Formula: C8H19NO5
Molecular Weight: 209.24 g/mol
CAS Number: 6976-37-0
The manufacturing of Bis-Tris, BTRI-3250 is performed at BioSpectra's Bangor, PA facility
Appears as white crystals
Manufactured under an ICH-Q7 Managed cGMP System
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 and its raw materials are not derived from nor come into contact with animal parts, animal byproducts, and/or animal byproducts or derivatives.
Is not subject to genetic modification
Synonyms: 2,2-Bis(hydroxymethyl)-2,2’,2’’- nitrilotriethanol; Bis(2-hydroxyethyl) aminotris(hydroxymethyl)methane; 2-(bis(2-hydroxyethyl)amino)-2(hydroxymethyl)-1,3-propanediol

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.

Standard 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 and Shipping Conditions:

Please refer to the SDS for storage and shipping conditions.

Package Sizes:

10kg, 25 kg and 50 kg pails.

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.