Tris HCl - GMP Buffer

BIO PHARMA GRADE | TH4220 | CAS# 1185-53-1

C of As and Tech Docs

INTENDED FOR USE IN PHARMACEUTICAL GMP PROCESSES

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BIO PHARMA GRADE / TH4220

CAS #: 1185-53-1

Molecular Formula:

C4H11NO3 • HCI

Solubility in Water (g/L): 1,010

F.W.: 157.60 g/mol

pH @ 20°C: 7.0 - 9.0

pKa @ 20˚C: 8.2

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
Absorbance (1M)

280 nm
0.06 a.u. max.
Appearance and Color White / Crystals
Assay, Dried 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.
Loss on Drying at 105oC 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 (1M) Passes Test
Trace Elements

Arsenic (As)

Calcium (Ca)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Magnesium (Mg)
5 ppm max. 
5 ppm max. 
5 ppm max. 
5 ppm max. 
5 ppm max. 
5 ppm max.
Printable Version
Key Compliance Attributes of
BioSpectra Grades		 Bio Pharma
Grade IPEC
GMP
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  
Available
Microbial / Endotoxin Tested  
Available
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
List of C of As files
TH4220-012-1020.pdf
TH4220-011-0720.pdf
TH4220-010-0520.pdf
TH4220-009-0919.pdf
TH4220-008-0919.pdf
TH4220-007-0919.pdf

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Review the below Intended End Use Statements for each Grade and Choose the Product Grade that is most applicable to your use.


a.) Bio Pharma Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.


b.) Bio Excipient Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


c.) O Bio Active Grade INTENDED USE: Material Represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in further Manufacturing or use in Drug Product Manufacturing. The material represented by this Grade is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item. (This statement will change depending on the status of your Drug Application in accordance with 21 CFR §201.122)

TRIS Hydrochloride General Product Description:

  • BioSpectra manufactures Tris Hydrochloride TH4220 in its Stroudsburg, PA facility.
  • 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 TH4220 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.


TRIS Hydrochloride GMP Compliance:

Bio Pharma Grade Tris Hydrochloride TH4220 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. This Grade of Tris Hydrochloride 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 Hydrochloride is two years from the date of manufacture..

Storage and Shipping Conditions:

Ship and Store in ambient temperature.

Package Sizes:

TRIS HCl is available in 10kg, 25kg and 50kg pails.