Tris API Active USP EP LBLE

API

ICH Q7 GMP Manufactured Active Ingredient

Tris

USP, LBLE*, GMP, API
Product Code: TRIS-2255

*Low Bioburden, Low Endotoxin

Minimum Order Quantity: Inquire
Lead Time: Inquire

Product Inquiry COAs Spec Sheet

Click the button above for pricing, lead times, MOQs and other inquiries.

Product Inquiry

Product(s) of Interest *

First Name *

Last Name *

Title & Position in Company *

Email *

Your Direct Phone Number & Country Code *

Name of Your Company *

Website of Your Company *

Address of Company *

Country where product is to be used *

Name of Your Customer – the End User *

Website of Your Customer – the End User *

Intended Application/Use if known

Package Size Requested *

Estimated Release Quantity per PO in Liters or Kgs *

Estimated Annual Demand in Liters or Kgs *

Regulatory or Compendial Requirements *

INCO Terms requested *

Available Package Sizes – Inquire for Pricing (Minimum Order Quantities May Apply)
100g	500g	1kg	5kg	10kg	25kg	50kg
Inquire	Inquire	Inquire	Inquire	Inquire	Inquire	Inquire

Product Code: TRIS-2255

Bio Active 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.

API Grade Tromethamine, TRIS-2255 is suitable for use as a non-Sterile Active Pharmaceutical Ingredient manufactured in accordance with the ICH Q7 Good Manufacturing Practice Guide. This grade of Tromethamine is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item.

CAS #: 77-86-1
Formula: NH₂C(CH₂OH)₃
F.W.: 121.14 g/mol
Solubility at 25˚C: 550 mg/mL
pH (5% aq. Solution): 10.0 - 11.5
pK_a at 25˚C: 8.07

Product Specifications

ANALYSIS

SPECIFICATIONS

Absorbance (40%)

290 nm

< = 0.2 a.u.

Appearance and Color

White Crystals

Assay, Dried Basis

99.0 - 101.0%

Endotoxin

< = 3.0 EU/g

Enzymes

DNase

RNase

Protease

None Detected

Elemental Impurities

Cadmium (Cd)

Lead (Pb)

Arsenic (As)

Mercury (Hg)

Cobalt (Co)

Vanadium (V)

Nickel (Ni)

Thallium (Tl)

Gold (Au)

Palladium (Pd)

Iridium (Ir)

Osmium (Os)

Rhodium (Rh)

Ruthenium (Ru)

Selenium (Se)

Silver (Ag)

Platinum (Pt)

Lithium (li)

Antimony (Sb)

Barium (Ba)

Molybdenum (Mo)

Copper (Cu)

Tin (Sn)

Chromium (Cr)

Aluminum (Al)

Calcium (Ca)

Iron (Fe)

Magnesium (Mg)

< = 0.005 ppm

< = 0.012 ppm

< = 0.036 ppm

< = 0.007 ppm

< = 0.012 ppm

< = 0.024 ppm

< = 0.079 ppm

< = 0.019 ppm

< = 0.238 ppm

< = 0.024 ppm

< = 0.191 ppm

< = 0.024 ppm

< = 0.595 ppm

< = 0.214 ppm

< = 1.667 ppm

< = 3.572 ppm

< = 0.714 ppm

< = 1.429 ppm

< = 2.619 ppm

< = 0.400 ppm

< = 1 ppm

Identification A, IR

Conforms to Reference Standard

Identification B

Passes Test

Identification C

Passes Test

Insoluble Matter

< = 0.005%

Loss on Drying

< = 1.0%

Melting Range

168-172 ºC

Microbial Content

Escherichia coli

Pseudomonas aeruginosa

Salmonella

Staphylococcus aureus

TAMC

TYMC

Absent/g

Absent/10g

Absent/g

< = 100 CFU/g

< = 10 CFU/g

Organic Impurities

2-Nitroethanol

2-Nitropropane-1,3-diol

Tris(hydroxymethyl) nitromethane

Formaldehyde

Any Unspecified Impurities

Total Impurities

< = 1 ppm

< = 15 ppm

< = 300 ppm

pH (5%)

10.0 – 11.5

Residue on Ignition

< = 0.1%

Residual Solvents

Methanol

Nitromethane

< = 300 ppm

< = 15 ppm

Water, KF

< = 2.0%

Printable Version

Key Product Features:

The manufacturing of Tris/Tromethamine, TRIS-2255 is performed at BioSpectra's Bangor, PA facility.
Appears as white crystals
Manufactured in accordance with ICH Q7
Manufactured in an enzyme free, hormone free, and animal free environment
Contains no known major food allergens (as defined by FDA and WHO)
The final product and its raw materials are not derived from nor come into contact with animal parts, animal products, and/or animal byproducts or derivatives.
Is not subject to genetic modification
Synonyms: Trometamol; THAM; Tris (Hydroxymethyl) Aminomethane; Trisaminol; Trismethylolaminomethane; 2- Amino-2 (Hydroxymethyl) propane-1,3-diol; Tromethamine

Shelf-Life Policy:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Storage & Shipping:

Refer to SDS.

Package Sizes:

10kg, 25kg, and 50kg

Bulk GMP Fine Chemicals exclusively manufactured in North America

American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.