ICH-Q7 GMP Manufactured Product
*Low Bioburden, Low Endotoxin
For Critical Analytical, Diagnostic and Pharmaceutical Applications, and downstream manufacture of drug products where a high purity, high assay, GMP Tris Hydrochloride is required. Tris Hydrochloride is a considered a “Good’s” buffer because it has low UV absorptivity, minimum reactivity, stable pH and is soluble in water.
CAS #: 1185-53-1
Formula: C4H11NO3·HCl
Sol. In H2O (g/L): 1,010
F.W.: 157.60 g/mol
pH @ 20°C: 4.5 - 6.0
Useful pH: 7.0-9.0
pKa @ 20˚C: 8.2
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ANALYSIS |
SPECIFICATIONS |
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≤ 0.06 a.u. ≤ 0.06 a.u. ≤ 0.01 a.u. |
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White, Crystalline Powder to Needle-Like Crystals | ||
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≥ 99.0% | ||
| Bioburden | ≤ 100 CFU/g | ||
| Endotoxin | ≤ 2.5 EU/g | ||
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None None None |
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Passes Test Passes Test |
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< 0.005% | ||
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≤ 0.5% | ||
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147–152ºC | ||
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4.0 - 5.0 3.5 - 5.0 |
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≤ 5 ppm |
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Water |
≤ 1.0% |
Printable Version
Plant or Animal Origin Statement: BioSpectra certifies that Tris, Product Code THCL-3257, manufactured by BioSpectra is of Synthetic origin. BioSpectra certifies that Tris, Product Code THCL-3257, is not derived from Plant or Animal Origin.
Metal Residue Statement: BioSpectra certifies that Tris, Product Code THCL-3257, manufactured by BioSpectra is manufactured without the use of metal catalysts and metal reagents. There are no known risks to metal residues in this product.
Melamine Statement: Based on the manufacturing process and the controlled handling, storage, and analysis of Tris, Product Code THCL-3257, BioSpectra certifies that there is low risk for melamine contamination. Additionally, when tested for melamine, this product reports less than 0.15 ppm.
Residual Solvents Statement: 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.
Bio Excipient Grade Tris Hydrochloride THCL-3257 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.
The recommended expiration period for Tromethamine Hydrochloride is three years from the date of manufacture.
Ship and store in ambient temperature. Store in a clean and dry area. Store in the original container.
10kg, 25kg and 50kg drums.
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.