Tris, ChP, GMP, Excipient

Excipient

ICH Q7 GMP Manufactured Product

Tris

Ch.P., LBLE*, GMP, Excipient
Product Code: TRIS-3251

*Low Bioburden, Low Endotoxin

Minimum Order Quantity: 500kg
Lead Time (if no stock): 3-months

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Product Code: TRIS-3251

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

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
pK_a at 25˚C: 8.07

Product Specifications

ANALYSIS

SPECIFICATIONS

Absorbance (1M)

260nm

280nm

430nm

< = 0.06 a.u.

< = 0.01 a.u.

Absorbance (10%)

260nm

280nm

430nm

< = 0.03 a.u.

< = 0.02 a.u.

< = 0.004 a.u.

Absorbance (40%)

290nm

< = 0.2 a.u.

APHA Color (20% Solution)

< = 20 APHA

Appearance and Color

White Crystals

Appearance of Solution (EP)

Passes Test

Assay, Dried Basis (USP/EP/ChP/JPC)

99.0 - 100.5%

Assay, Dried Basis (Ultrapure)

> = 99.9%

Chloride (ChP/EP)

< = 100 ppm

Clarity and Color of Solution (ChP/JPC)

Passes Test

Endotoxin

< = 2.5 EU/g

Enzymes

DNase

Protease

RNase

None Detected

Identification, IR (USP-A/ChP-3/EP-C)

Conforms to Reference Standard

Identification A (EP), pH (5%) (USP/ChP/EP)

10.0 - 11.5

Identification A (JPC)

Passes Test

Identification B (USP/ChP-1)

Passes Test

Identification B (EP), Melting Range (USP/ChP/JPC)

168 – 172˚C

Identification B (JPC)

Passes Test

Identification C (USP)

Passes Test

Identification D (EP/ChP-2)

Passes Test

Insoluble Matter

< = 0.005%

Loss on Drying (USP/ChP/EP/JPC)

< = 0.3%

Residual Solvents

Methanol

< = 3000 ppm

Microbial Content

TAMC

TYMC

Bile tolerant Gram Neg. Bacteria

Escherichia coli

Pseudomonas aeruginosa

Staphylococcus aureus

Candida albicans

Salmonella sp.

< = 100 CFU/g

Absent/g

Absent/10g

pH (1 in 100) (JPC)

10.3 - 10.7

Related Substances (ChP/EP)

< = 0.1%

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

< = 0.05%

Trace Metals

Arsenic (As)

Calcium (Ca)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Magnesium (Mg)

Manganese (Mn)

Nickel (Ni)

Zinc (Zn)

< = 1.6 ppm

< = 1 ppm

< = 5 ppm

< = 1 ppm

< = 15 ppm

< = 1 ppm

Water, KF

< = 1.0%

Printable Version

Key Product Features:

The manufacturing of Tris, TRIS-3251 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: Trometamol; THAM; Tris (Hydroxymethyl) Aminomethane; Trisaminol; Trismethylolaminomethane; 2-Amino-2 (Hydroxymethyl) propane-1,3-diol; Tromethamine

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 pails.

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.