ICH Q7 GMP Manufactured Product
USP, EP, JPC, LBLE*, GMP, Excipient
Product Code: TRIS-3255
*Low Bioburden, Low Endotoxin
Minimum Order Quantity: 500kg
Lead Time (if no stock): 3-months
Tromethamine (Tris) is commonly used as a buffer and excipient in downstream biological applications during the manufacture of drug products. Tris is considered a Good’s buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water.
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
pKa at 25˚C: 8.07
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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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< = 0.03 a.u. < = 0.02 a.u. < = 0.004 a.u. |
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| APHA Color (20% Solution) | < = 20 APHA | ||
| Appearance and Color | White, Crystalline Powder to Needle Like Crystals | ||
| Appearance of Solution (EP) | Passes Test | ||
| Assay, Dried Basis (USP/EP/JPC) | 99.0 - 100.5% | ||
| Assay, Dried Basis (Ultrapure) | > = 99.0% | ||
| Chloride (EP) | < = 100 ppm | ||
| Clarity and Color of Solution (JPC) | Passes Test | ||
| Endotoxin | < = 2.5 EU/g | ||
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None Detected None Detected None Detected |
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| Identification, IR (USP-A/EP-C) | Conforms to Reference Standard | ||
| Identification A (EP), pH 5% (USP/EP) | 10.0 - 11.5 | ||
| Identification A (JPC) | Passes Test | ||
| Identification B (USP) | Passes Test | ||
| Identification B (EP), Melting Range (USP/JPC) | 168 - 172˚C | ||
| Identification B (JPC) | Passes Test | ||
| Identification C (USP) | Passes Test | ||
| Identification D (EP) | Conforms to Reference Standard | ||
| Insoluble Matter | < = 0.005% | ||
| Loss on Drying (USP/EP/JPC) | < = 0.3% | ||
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< = 100 CFU/g < = 100 CFU/g |
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| pH (1 in 100) (JPC) | 10.3 - 10.7 | ||
| Related Substances (EP) | < = 0.1% | ||
| Residue on Ignition / Sulfated Ash (USP/EP/JPC) | < = 0.05% | ||
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< = 1.6 ppm < = 1 ppm < = 1 ppm < = 1 ppm < = 1 ppm < = 5 ppm < = 1 ppm < = 1 ppm |
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| Water, KF | < = 1.0% |
Printable Version
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).
Refer to SDS.
10kg, 25kg, and 50kg
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.