GMP Manufactured Product
Low Bioburden, Low Endotoxin, GMP Manufactured
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.
CAS #: 124763-51-5
Molecular Formula: C8H19NO5·HCl
pH 1% @ 25°C: 3.8 - 4.4
F.W.: 245.70 g/mol
| Analysis | Specifications | ||
|---|---|---|---|
|
≤ 0.05 a.u. ≤ 0.03 a.u. |
||
|
White Crystals | ||
|
≥ 99.0% | ||
| Bioburden | ≤ 100 CFU/g | ||
| Endotoxin | ≤ 50 EU/g | ||
|
None Detected |
||
|
Passes Test |
||
|
3.8 – 4.4 |
||
|
Passes Test | ||
|
≤ 1.0% |
Printable Version
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
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.
The recommended retest period for Bis-Tris HCl is two years from the date of manufacture.
Keep container tightly closed in a dry and well-ventilated place.
10kg, 25 kg and 50 kg pails.
India
This product is then repacked and retested under cGMP at our Bangor USA cGMP FDA Regulated Facility.
Plant or Animal Origin Statement: BioSpectra certifies that Tris, Product Code THCL-3257, manufactured by BioSpectra is of Synthetic origin. BioSpectra certifies that Tris, Product Code THCL-3257, is not derived from Plant or Animal Origin.
Metal Residue Statement: BioSpectra certifies that Tris, Product Code THCL-3257, manufactured by BioSpectra is manufactured without the use of metal catalysts and metal reagents. There are no known risks to metal residues in this product
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.