TRIS HCl - Excipient

BIO EXCIPIENT GRADE | TH3220 | CAS# 1185-53-1

INTENDED FOR USE AS AN EXCIPIENT

Product-image

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.

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BIO EXCIPIENT GRADE / TH3220

CAS #: 1185-53-1

Molecular Formula:

C4H11NO3HCl

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

 
ANALYSIS SPECIFICATIONS
Absorbance 280 nm
 
0.6 a.u. max.
Appearance and Color  
White / Crystals
Assay  
99.5% min.
Enzymes

DNase

RNase
Protease

 

None Detected
None Detected
None Detected
Heavy Metals  
2 ppm max.
Identification (IR)  
Passes Test
Insoluble Matter  
0.001% max.
Karl Fischer  
0.5% max.
Melting Range  
150 – 153 ˚C
pH(0.5M)  
4.0 – 5.0
pKa  
8.0 – 8.4
Residue on Ignition  
0.1% max.

Solubility

 
Passes Test
Trace Metals Arsenic (As)
Calcium (Ca), 
Copper (Cu)
Iron (Fe)
Lead (Pb)
Magnesium(Mg)
 1 ppm max.
 1 ppm max.
 1 ppm max.
 1 ppm max.
 1 ppm max.
1 ppm max.
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes
Each Batch 100% Analyzed  
Yes
Management of Change  
Yes
Validated Analytical Methods  
Yes
Compendial Testing  
Yes
Trace Metals Analyzed  
Yes
Two Year Stability  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Yes
Enzyme Tested  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Suitable for use as Excipient  
Yes
Microbial / Endotoxin Tested  
Yes
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
Type IV Drug Master File  
Available
Video Conference access to BioSpectra Sites  
Available
Complete access to Product Traceability  
Available
Access to Supply Chain Information  
Yes
ICH Q7 Qualified Utilities  
Yes
ICH Q7 Compliant Manufactured  
Yes
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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: NH2C(CH2OH)3
  • 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, Tromethamine, Tri (Hydroxymethyl) Amino Methane 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.