ICH-Q7 GMP Manufactured Product
TRIS HCl
*Low Bioburden, Low Endotoxin
Tris Hydrochloride is a stabilizing buffer in biological applications such as electrochromatography, UV analysis and HPLC. It is used to adjust and stabilize the pH ranges for gels used in electrophoresis applications. Tris Hydrochloride is extensively used as a biological buffer or a component of buffer solutions.
CAS #: 1185-53-1
Formula: C4H11NO3·HCl
Sol. In H2O (g/L): 1,010
F.W.: 157.60 g/mol
pH @ 20°C: 4.5-6.0
Useful pH: 7.0-9.0
pKa @ 20˚C: 8.2
Product Specifications
| Analysis | Specifications | ||
|---|---|---|---|
|
≤ 0.06 a.u. ≤ 0.06 a.u. ≤ 0.01 a.u. |
||
|
White / Crystals | ||
|
99.5% - 101% | ||
| Bioburden | ≤ 100 CFU/g | ||
| Endotoxin | ≤ 2.5 EU/g | ||
|
None None None |
||
|
2 ppm max. | ||
|
Passes Test Passes Test |
||
|
0.001% max. | ||
|
≤ 0.5% | ||
|
150–152ºC | ||
|
4.0-5.0 3.5-5.0 |
||
| Residue on Ignition | 0.1% max. | ||
|
Passes Test | ||
|
1 ppm max. |
||
|
Water (Karl Fischer) |
≤ 0.5% |
Printable Version
General Product Description:
- The manufacturing of Tris Hydrochloride THCL-3260 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
- Tris Hydrochloride is a White Crystalline product
- Molecular Formula: C4H11NO3 • HCI
- Molecular Weight: 157.60 g/mol.
- CAS Number: 1185-53-1
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all Tris Hydrochloride THCL-3260 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
- Tris Hydrochloride manufactured at BioSpectra and any raw materials used in the manufacture of Tris Hydrochloride at BioSpectra are not subject to genetic modification.
- Synonyms: Tris Hydrochloride, 2-Amino-2-(Hydroxymethyl)- 1,3-Propanediol Hydrochloride; Tris (Hydroxymethyl) Aminomethane Hydrochloride
GMP Compliance:
Bio Excipient Grade Tris Hydrochloride THCL-3260 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tris Hydrochloride is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Product Statements:
RESIDUAL SOLVENTS: Based on the manufacturing process and the controlled handling, storage and analysis of this product, this product complies with the requirements and specifications listed in the current USP method <467> Tables 1, 2, 3, or 4.
Expiration:
The recommended expiration period for Tromethamine Hydrochloride is three years from the date of manufacture.
Storage and Shipping Conditions:
Ship and store in ambient temperature. Store in a clean and dry area. Store in the original container.
Package Sizes:
10kg, 25kg and 50kg drums.
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.