Tris(hydroxymethyl)aminomethane (TRIS, Trometamol) USP, Multi-Compendial, J.T.Baker®

Supplier: Avantor
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BAKR4101-09EA 0 SGD
BAKR4101-09 BAKR4101-07
Tris(hydroxymethyl)aminomethane (TRIS, Trometamol) USP, Multi-Compendial, J.T.Baker®
Tris(hydroxymethyl)aminomethane (TRIS, Trometamol)
Formula: NH₂C(CH₂OH)₃
MDL Number: MFCD00004679
CAS Number: 77-86-1

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Specification Test Results

Meets B.P. Chemical Specifications
Meets E.P. Chemical Specifications
GMP Manufactured Product
Meets JPC (1997) Chemical Specifications
Meets U.S.P Requirements
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
USP - Assay (C₄H₁₁NO₃) 99.0 - 101.0 %
USP - Identification A Passes Test
USP - Identification B Passes Test
USP - Identification C Passes Test
USP - pH (1 in 20) 10.0 - 11.5
USP - Residue on Ignition ≤0.1 %
USP - Loss on Drying ≤0.5 %
USP - Melting Range(Lower) 168 - 172 °C
USP - Melting Range(Upper) 168 - 172 °C
EP/BP - Assay (C₄H₁₁NO₃) (dried basis) 99.0 - 100.5 %
EP/BP - Identification B Passes Test
EP/BP - Identification C Passes Test
EP/BP - Appearance of Solution Passes Test
EP/BP - pH 10.0 - 11.5
EP/BP - Related Substances ≤1.0 %
EP/BP - Chloride (Cl) ≤100 ppm
EP/BP - Iron (Fe) ≤10 ppm
EP/BP - Loss on Drying at 105°C ≤0.5 %
EP/BP - Ash (sulfated) ≤0.1 %
JPC 1997 - Assay (C₄H₁₁NO₃) (dried basis) ≥99.0 %
JPC 1997 - Identification A Passes Test
JPC 1997 - Identification B Passes Test
JPC 1997 - pH 10.3 - 10.7
JPC 1997 - Melting Point 168 - 172 °C
JP - Clarity and Color of Solution Passes Test
JPC 1997 - Heavy Metals (as Pb) ≤8 ppm
JPC 1997 - Arsenic (As) ≤1.6 ppm
JPC 1997 - Loss on Drying ≤0.5 %
JPC 1997 - Residue on Ignition ≤0.10 %
Assay (C₄H₁₁NO₃) (dried basis) ≥99.9 %
Absorbance of a 1M Solution - 260 nm ≤0.06
Absorbance of a 1M Solution - 280 nm ≤0.06
Absorbance of a 1M Solution - 400 nm ≤0.01
Endotoxin Concentration (EU/g) ≤2.5
Iron (Fe) ≤1 ppm
Lead (Pb) ≤1 ppm
Water (H₂O)(by Karl Fischer titrn) ≤0.5 %
Enzyme Activity - DNase Activity Passes Test
Enzyme Activity - RNase Activity Passes Test
Enzyme Activity - Protease Activity Passes Test
Trace Impurities - Arsenic (As) ≤1 ppm
Trace Impurities - Aluminum (Al) ≤5.000 ppm
Trace Impurities - Barium (Ba) ≤5 ppm
Trace Impurities - Bismuth (Bi) ≤5 ppm
Trace Impurities - Calcium (Ca) ≤10.0 ppm
Trace Impurities - Cadmium (Cd) ≤5.000 ppm
Trace Impurities - Chromium (CR) ≤5 ppm
Trace Impurities - Cobalt (Co) ≤5.000 ppm
Trace Impurities - Copper (Cu) ≤5 ppm
Trace Impurities - Lithium (Li) ≤5 ppm
Trace Impurities - Magnesium (Mg) ≤5 ppm
Trace Impurities - Mercury (Hg) ≤5 ppm
Trace Impurities - Molybdenum (Mo) ≤5 ppm
Trace Impurities - Nickel (Ni) ≤5.000 ppm
Trace Impurities - Potassium (K) ≤50 ppm
Trace Impurities - Sodium (Na) ≤50.000 ppm
Trace Impurities - Strontium (Sr) ≤5 ppm
Trace Impurities - Vanadium (V) ≤5.000 ppm
Trace Impurities - Zinc (Zn) ≤5.000 ppm
No Class 1,2,3 or other solvents are used or produced in the
manufacturing or purification of the product.
Elemental Impurities (USP 232, EP 5.20) - Information on elemental
impurities for this product is available on the associated Product
Regulatory Data Sheet and elemental impurity profile report.

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