Tromethamine (Tris) - Bio Active LBLE

BIO ACTIVE LBLE GRADE | TR2250 | CAS# 77-86-1

C of As and Tech Docs

INTENDED FOR USE AS AN ACTIVE PHARMACEUTICAL INGREDIENT

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BIO ACTIVE LBLE GRADE | TR2250

CAS #: 77-86-1

Molecular Formula:

C4H11NO3

Solubility in Water @ 25°C (g/L): 550

F.W.: 121.14 g/mol

pH @ 20°C (5% aq. Soln.): 10.0 - 11.5

Useful pH: 7.0 - 9.0

pKa @ 20˚C: 8.3

Bio Active LBLE Grade of Tromethamine is intended to be used in parenteral drug formulations as an Active Pharmaceutical Ingredient. This product is not to be considered sterile and requires further terminal sterilization.


These are general specifications. BioSpectra will customize our products to meet your quality based requirements.

ANALYSIS SPECIFICATIONS
Absorbance (40%) 290 nm
0.2 a.u. max.
Appearance and Color White / Crystals
Assay 99.0-101.0%
Bacterial Endotoxins 3.0 EU/g max.
  DNase
Enzymes RNase
  Protease
None Detected
None Detected
None Detected
Heavy Metals (as Pb) 0.5 ppm max.
Identification B Passes Test
Identification C Passes Test
Identification (IR) Passes Test
Insoluble Matter 0.005% max.
Karl Fischer Water 2% max.
LOD 1.0% max.
Melting Range

168-172ºC

  Microbial Content    Escherichia coli
Pseudomonas aeruginosa
Salmonella
Staphylococcus aureus
TAMC
TYMC
Negative
Negative
Negative
Negative
100 CFU/g max.
10 CFU/g max.
  2-Nitropropane-1, 3-diol
  Tris(hydroxymethyl) nitromethane
Organic Impurities 2-Nitroethanol
  Total Unspecified Impurities
  Formaldehyde
NMT 1 ppm
NMT 1 ppm
NMT 1 ppm
NMT 300 ppm
NMT 1 ppm
pH (1 in 20)

10.0-11.5

Residual Solvents

Methanol

Nitromethane

≤ 300 ppm

≤ 15 ppm

Residue on Ignition

0.1% max.

  Aluminum (Al)
  Arsenic (As)
  Calcium (Ca)
Trace Metals Copper (Cu)
  Iron (Fe)
  Lead (Pb)
  Magnesium (Mg)
  Nickel (Ni)
1 ppm max.
1 ppm max.
1 ppm max.
1 ppm max.
1 ppm max.
0.5 ppm max.
1 ppm max.
0.4 ppm max.
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Active 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  
Yes
Customized Manufacturing Schedule  
Yes
Custom Regulatory Packet  
Yes
Accelerated Stability  
Yes
Type IV Drug Master File  
N/A
Video Conference access to BioSpectra Sites  
Yes
Complete access to Product Traceability  
Yes
Access to Supply Chain Information  
Yes
ICH Q7 Qualified Utilities  
Yes
ICH Q7 Compliant Manufactured  
Yes
Suitable for use as Active Ingredient  
Yes
Type II Drug Master File  
Available

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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)

General Product Description:

  • The manufacturing of Bio Active LBLE Grade Tromethamine TR2250 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of Bio Active LBLE Grade Tromethamine TR2250 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
  • Tromethamine is a White Crystalline product.
  • Molecular Formula: NH2C(CH2OH)3
  • Molecular Weight: 121.14 g/mol.
  • CAS Number: 77-86-1.
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
  • BioSpectra certifies that all Tromethamine TR2250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
  • Tromethamine manufactured at BioSpectra and any raw materials used in the manufacture of Tromethamine at BioSpectra are not subject to genetic modification.
  • Synonyms: Tris, Tromethamine, Tris (hydroxymethyl) aminomethane.


GMP Compliance:

Bio Active LBLE Grade Tromethamine TR2250 is manufactured in
accordance with ICH Q7 cGMP guidelines including sections 4.34
& 12.75 and is suitable to be used only as the following: non-
Sterile ICH Q7 compliant Active Pharmaceutical Ingredient for use
in further processing to produce a Sterile Drug Product. This grade
of Tromethamine is not suitable to be used as a sterile Active
Pharmaceutical Ingredient, 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:

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

Package Sizes:

10kg, 25kg and 50kg pails.