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 Crystalline Powder

Assay (Dried Basis)

99.0% - 101.0%

Bioburden

TAMC
TYMC

≤ 100 CFU/g
≤ 100 CFU/g

Chloride

< 0.005%

Endotoxin

≤ 50 EU/g

Enzymes

DNase
Protease
RNase

None Detected
None Detected
None Detected

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

6.3 – 6.7

Residue on Ignition (ROI)

≤ 0.1%

Solubility 0.1M in H₂O (USP)

Clear and Complete

Water (KF)

≤ 1.0%

Printable Version

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.

Retest Date:

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

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.