Product Category

Excipient

ICH-Q7 GMP Manufactured Product

TRIS HCl, LBLE,
GMP Standard Excipient Grade

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: THCL-3250 | Previously: TH3250

Intended For Use As An Excipient


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.

Product Specifications

ANALYSIS

SPECIFICATIONS

Absorbance (1M)

260nm

280nm

400nm

≤ 0.06 a.u.

≤ 0.06 a.u.

≤ 0.01 a.u.

Appearance  
Passes Test
Assay, Dried  
≥ 99.0%
Bioburden ≤ 100 CFU/g 
Endotoxin ≤ 2.5 EU/g
Enzymes

DNase
RNase
Protease

None
None
None
Identification

(IR)

(Chloride)

Passes Test

Passes Test

Loss on Drying @ 105°C  
≤ 0.5%
Melting Range  
147–152ºC
pH

(1% Aqueous Solution)

(0.5M) @ 25°C 

4.0-5.0

3.5-5.0

Trace Metals

Arsenic (As)
Calcium (Ca)
Copper (Cu)
Iron (Fe)
Lead (Pb)
Magnesium (Mg)

≤ 10 ppm 
≤ 10 ppm
≤ 10 ppm
≤ 10 ppm
≤ 10 ppm
≤ 10 ppm

Water

≤ 2.0%

Printable Version

Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH-Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
Customized Additional Specifications  
Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image
ICH-Q7 Qualified Utilities  
Yes-image
ICH-Q7 Compliant Manufactured  
Yes-image
Type II Drug Master File  
Yes-image

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient 
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.

 

Product Inquiry

Please enter your first name

Please enter title

Please enter product of interest

Enter name of company

Please enter your last name

Please enter your valid email address

Enter position in company

Location of company
Please enter street address

Enter your company state

Invalid Input

Please enter city

Enter zip code

Enter Country

Enter country code

Enter phone number

Enter web address

Please select any option

If resale please fill out the following information
Enter end use customer's full name

Enter end use customer's address

Please select any option

Please select any one option

Please select any option

Invalid Input

Please select any one option

Invalid Input

Invalid Input

Please enter Estimated Release quantity in Liters or Kg

Please enter Regulatory Requirements

Please enter timeframe needed

Please enter Estimated annual demand in liters or kg

Please enter Logistics: Freight

Please enter specificatoin

Validate Recaptcha

General Product Description:

  • The manufacturing of Tris Hydrochloride THCL-3250 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-3250 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-3250 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.

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. Store in a clean and dry area. Store in the original container.

Package Sizes:

10kg, 25kg and 50kg drums.

Additional Packaging Information

https://www.biospectra.us/technical/packaging