Excipient
ICH Q7 GMP Manufactured Product
TRIS Hydrochloride
Endotoxin Tested, GMP, Excipient
Product Code: THCL-3253
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COAs
Spec Sheet
Product Code: THCL-3253
Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.
Tris Hydrochloride is a stabilizing buffer in biological applications such as electrochromatography, UV analysis and HPLC. It is used to adjust and stabilize the pH ranges for gels used in electrophoresis applications. Tris Hydrochloride is extensively used as a biological buffer or a component of buffer solutions.
CAS #: 1185-53-1
Formula: NH2C(CH2OH)3 · HCl
F.W.: 157.60 g/mol
IOU: {LIL/SAM}
Product Specifications
| Analysis | Specifications | ||
|---|---|---|---|
|
< = 0.06 a.u. < = 0.06 a.u. < = 0.01 a.u. |
||
| Appearance and Color | White to Off White Crystalline Powder or Granules | ||
| Assay, Dried Basis | > = 99.0% | ||
| Endotoxin | < = 2.5 EU/g | ||
| Identification, IR |
Conforms to Reference Standard |
||
| Loss on Drying | < = 0.5% | ||
| Melting Range |
150 - 153°C |
||
| pH (0.5M) | 3.5 - 5.0 | ||
|
< = 10 ppm < = 10 ppm < = 10 ppm < = 10 ppm < = 10 ppm < = 10 ppm |
Key Product Features:
- The manufacturing of Tris Hydrochloride, THCL-3253 is performed at BioSpectra's Stroudsburg, 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: 2-Amino-2-(Hydroxymethyl)propane-1,3-diol hydrochloride; Tri(Hydroxymethyl) Aminomethane Hydrochloride
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.