Product Category

Excipient

ICH-Q7 GMP Manufactured Product

BIS-TRIS HCl, LBLE, GMP Excipient Grade

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: BTHY-3250

Intended For Use As An Excipient


BIS-TRIS HCl, is the chlorinated version of BIS-TRIS, a zwitterionic biological buffer often used in biological pharmaceutical manufacturing for extraction, separation and purification, as well as an intermediate in synthetic reactions and as a process aid in peptide synthesis.

Product Specifications

ANALYSIS

SPECIFICATIONS

Absorbance (0.1M)

260nm

290nm

≤ 0.05 a.u.

≤ 0.03 a.u.

Appearance and Color  
White Crystals
Assay (Titration)  
≥ 99.0%
Bioburden ≤ 100 CFU/g 
Endotoxin ≤ 50 EU/g
Enzymes

DNase
Protease
RNase

None Detected
None Detected
None Detected
Identification (IR)

 

Passes Test

pH (1.0%) @ 25°C

 

3.8 – 4.4

Solubility (0.1M)

 
Passes Test

Water Content (KF)

 

≤ 1.0%

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.

 

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formula-image

COAs and Tech Docs

formula-image

BTHY-3250

CAS #: 124763-51-5

Formula: C8H19NO5·HCl

pH 1% @ 25°C: 3.8 - 4.4

F.W.: 245.70 g/mol

General Product Description:

  • The manufacturing of Bis-Tris HCl BTHY-3250 is performed at BioSpectra’s Bangor, PA facility and is conducted in a dedicated processing area using only dedicated equipment.

  • Bis-Tris HCl is a White Crystalline product

  • Molecular Formula: C8H19NO5 • HCl

  • Molecular Weight: 245.70 g/mol

  • CAS Number: 124763-51-5

  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.

  • Biospectra certifies that all Bis-Tris HCl BTHY-3250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts. Bis-Tris HCl manufactured at BioSpectra and any raw materials used in the manufacture of Bis-Tris HCl at BioSpectra are not subject to genetic modification.

  • Synonyms: 2,2-Bis(hydroxymethyl)-2,2’,2”- nitrilotriethanol, BIS-TRIS hydrochloride, Bis(2- hydroxyethyl)aminotris(hydroxymethyl)methane, 2-Bis(2-hydroxyethyl)amino-2-(hydroxymethyl)-1,3- propanediol 

 


GMP Compliance:

Bio Excipient Grade Bis-Tris HCl BTHY-3250 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Bis-Tris HCl is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Retest Date:

The recommended retest period for Bis-Tris HCl is two years from the date of manufacture.

Storage and Shipping Conditions:

Keep container tightly closed in a dry and well-ventilated place.

Package Sizes:

10kg, 25 kg and 50 kg pails.

Additional Packaging Information

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