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Product Category

Excipient

GMP Manufactured Product

BIS-TRIS HCl, LBLE, GMP Excipient Grade

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: BTHY-4250

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Intended For Use As An Excipient


BIS-TRIS HCl, is the chlorinated version of BIS-TRIS, a zwitterionic biological buffer often used in biological pharmaceutical manufacturing for extraction, separation and purification, as well as an intermediate in synthetic reactions and as a process aid in peptide synthesis.

Product Specifications

ANALYSIS

SPECIFICATIONS
Absorbance (0.1M)

260nm

290nm

≤ 0.05 a.u.

≤ 0.03 a.u.
Appearance and Color  
White Crystals
Assay (Titration)  
≥ 99.0%
Bioburden ≤ 100 CFU/g 
Endotoxin ≤ 50 EU/g
Enzymes

DNase
Protease
RNase
None Detected
None Detected
None Detected
Identification (IR)

 

Passes Test

pH (1.0% @ 25°C)

  

3.8 – 4.4

Solubility (0.1M)

  
Passes Test

Water Content (KF)

  

≤ 1.0%

Printable Version

List of C of As files
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COAs and Tech Docs

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BTHY-4250

CAS #: 124763-51-5

Formula: C8H19NO5·HCl

pH 1% @ 25°C: 3.8 - 4.4

F.W.: 245.70 g/mol

General Product Description:

  • Bis-Tris HCl is produced at our cGMP platform in India and then shipped to our Bangor, PA facility where it is tested and repackaged under cGMP conditions.

  • Bis-Tris HCl is a White Crystalline product.

  • Molecular Formula: C8H19NO5 • HCl

  • Molecular Weight: 245.70 g/mol

  • CAS Number: 124763-51-5

  • 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 HCl BTHY-4250 manufactured at our cGMP platform in India and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts. Bis-Tris HCl manufactured at BioSpectra and any raw materials used in the manufacture of Bis-Tris HCl at BioSpectra are not subject to genetic modification.

  • Synonyms: 2,2-Bis(hydroxymethyl)-2,2’,2”- nitrilotriethanol, BIS-TRIS hydrochloride, Bis(2- hydroxyethyl)aminotris(hydroxymethyl)methane, 2-Bis(2-hydroxyethyl)amino-2-(hydroxymethyl)-1,3- propanediol 

 


GMP Compliance:

Bio Pharma Grade Bis-Tris HCl BTHY-4250 is suitable for use as an excipient. It is manufactured in accordance with the IPEC-PQG Joint Good Manufacturing Practice Guide For Excipients. This grade of Bis-Tris HCl is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

Retest Date:

The recommended retest period for Bis-Tris HCl is two years from the date of manufacture.

Storage and Shipping Conditions:

Keep container tightly closed in a dry and well-ventilated place.

Package Sizes:

10kg, 25 kg and 50 kg pails.

Country of Origin

India

This product is then repacked and retested under cGMP at our Bangor USA cGMP FDA Regulated Facility.

Additional Packaging Information

https://www.biospectra.us/technical/packaging