Tris USP EP JPC GMP

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Excipient

ICH Q7 GMP Manufactured Product

Tris / Tromethamine

USP, EP, JPC, BET*, GMP, Excipient
Product Code: TRIS-3257

*Bioburden and Endotoxin Tested

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Product Code: TRIS-3257

Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.

Tris/Tromethamine 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)₃F.W.: 121.14 g/mol
Solubility at 25˚C: 550 mg/mL
pH (5% aq. Solution): 10.0 - 11.5
pK_a at 25˚C: 8.07

Product Specifications

ANALYSIS

SPECIFICATIONS

Absorbance (1M)

260 nm

280 nm

300 nm

< = 0.05 a.u.

< = 0.004 a.u.

Absorbance (10%)

260 nm

280 nm

430 nm

< = 0.03 a.u.

< = 0.02 a.u.

< = 0.004 a.u.

Absorbance (40%)

290 nm

< = 0.01 a.u.

APHA Color (20% Solution)

< = 20 APHA

Appearance of Solution (EP)

Passes Test

Assay, Dried Basis (USP/EP/JPC)

99.0 - 100.5%

Assay, Dried Basis (Ultrapure)

> = 99.5%

Chloride (EP)

< = 20 ppm

Clarity and Color of Solution (JPC)

Passes Test

Endotoxin

< = 2.5 EU/g

Enzymes

DNase

Protease

RNase

None Detected

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%

Microbial Content

TAMC

TYMC

Bile Tolerant Gram Neg. Bacteria

Escherichia coli

Pseudomonas aeruginosa

Staphylococcus aureus

Candida albicans

Salmonella sp.

< = 50 CFU/g

Absent/g

Absent/10g

Non-Volatile Residue (JPC)

< = 0.10%

Odor (JPC)

Passes Test

pH (1 in 100) (JPC)

10.3 – 10.7

Related Substances (EP)

< = 0.1%

Residual Solvents

2-Propanol

< = 0.5%

Residue on Ignition / Sulfated Ash (USP/EP/JPC)

< = 0.05%

Solubility (40%)

< = 0.20%

Sulfate

< = 5 ppm

Trace Metals

Aluminum (Al)

Arsenic (As) (JPC)

Barium (Ba)

Bismuth (Bi)

Cadmium (Cd)

Calcium (Ca)

Chromium (Cr)

Cobalt (Co)

Copper (Cu)

Iron (Fe) (EP)

Lead (Pb) (JPC)

Lithium (Li)

Potassium (K)

Magnesium (Mg)

Manganese (Mn)

Molybdenum (Mo)

Nickel (Ni)

Sodium (Na)

Strontium (Sr)

Zinc (Zn)

< = 5 ppm

< = 0.2 ppm

< = 1 ppm

< = 50 ppm

< = 5 ppm

< = 1 ppm

< = 2.5 ppm

< = 50 ppm

< = 5 ppm

< = 1 ppm

Volatile Residue (JPC)

< = 0.5%

Water, KF

< = 0.5%

Printable Version

Key Product Features:

The manufacturing of Tris/Tromethamine, TRIS-3257 is performed at BioSpectra’s Stroudsburg, PA facility.
Appears as a white crystalline powder
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: Trometamol; THAM; Tris (Hydroxymethyl) Aminomethane; Trisaminol; Trismethylolaminomethane; 2-Amino-2 (Hydroxymethyl) propane-1,3-diol

Storage & Shipping:

Refer to SDS.

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).

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.