ICH-Q7 GMP Manufactured Product
TRIS HCl
*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
Product Specifications
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ANALYSIS |
SPECIFICATIONS |
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|---|---|---|---|
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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
General Product Description:
- The manufacturing of Tris Hydrochloride THCL-3257 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
- Tris Hydrochloride (HCl) Buffer is a White Crystalline product
- Molecular Formula: C4H11NO3 • HCI
- Molecular Weight: 157.60 g/mol.
- CAS Number: 1185-53-1
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all Tris Hydrochloride (HCl) Buffer THCL-3257 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
- Tris Hydrochloride (HCl) Buffer manufactured at BioSpectra and any raw materials used in the manufacture of Tris Hydrochloride at BioSpectra are not subject to genetic modification.
- Synonyms: Tris Hydrochloride (HCl), 2-Amino-2-(Hydroxymethyl)- 1,3-Propanediol Hydrochloride; Tris (Hydroxymethyl) Aminomethane Hydrochloride
Product Statements:
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.
GMP Compliance:
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.
Expiration:
The recommended expiration period for Tromethamine Hydrochloride is three years from the date of manufacture.
Storage and Shipping Conditions:
Ship and store in ambient temperature. Store in a clean and dry area. Store in the original container.
Package Sizes:
10kg, 25kg and 50kg drums.
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.