ICH-Q7 GMP Manufactured Product
TRIS HCl
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 | |||
|---|---|---|---|---|
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|
|||
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White / Crystals | |||
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99.5% min. | |||
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None Detected |
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2 ppm max. | |||
|
Passes Test | |||
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0.001% max. | |||
|
0.5% max. | |||
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150–153˚C | |||
|
4.0 - 5.0 | |||
| pKa | 8.0 - 8.4 | |||
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0.5% max. | |||
| Solubility | Passes Test | |||
|
1 ppm max. 1 ppm max. 1 ppm max. 1 ppm max. 1 ppm max. 1 ppm max. |
Printable Version
General Product Description:
- The manufacturing of Tris Hydrochloride THCL-3220 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
- Tris HCl 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-3220 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-3220 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.
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.
Package Sizes:
10kg, 25kg and 50kg 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.