TRIS HCl - Excipient
BIO EXCIPIENT GRADE | TH3220 | CAS# 1185-53-1
INTENDED FOR USE AS AN EXCIPIENT
BIO EXCIPIENT GRADE / TH3220
CAS #: 1185-53-1
Molecular Formula:
C4H11NO3 • HCI
Solubility in Water (g/L): 1010
F.W.: 157.60 g/mol
pH @ 20°C: 4.5 - 6.0
Useful pH: 7.0 - 9.0
pKa @ 20˚C: 8.2
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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.
These are general specifications. BioSpectra will customize our products to meet your quality based requirements.
| ANALYSIS | SPECIFICATIONS | |||
|---|---|---|---|---|
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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. | |||
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Passes Test | |||
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0.001% max. | |||
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0.5% max. | |||
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150 – 153 ˚C | |||
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4.0 – 5.0 | |||
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8.0 – 8.4 | |||
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0.1% max. | |||
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Passes Test | |||
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1 ppm max. 1 ppm max. 1 ppm max. 1 ppm max. 1 ppm max. 1 ppm max. |
| Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH Q7 Compliant Manufactured | ||
|---|---|---|---|
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Yes | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Available | ||
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Yes | ||
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Yes | ||
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Yes |
General Product Description:
- The manufacturing of Tris Hydrochloride TH3220 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 TH3220 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 TH3220 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient,
for use in further Manufacturing. This Grade of Tromethamine is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.
Expiration/Retest Date:
The recommended retest period for Tromethamine is two years
from the date of manufacture.
Storage and Shipping Conditions:
Ship and Store in ambient temperature.
Package Sizes:
10kg, 25kg and 50kg pails.