Tris Excipient

Excipient

ICH-Q7 GMP Manufactured Product

Tris Excipient

USP, EP, LBLE*, GMP, Excipient Grade
Product Code: TRIS-3254

*Low Bioburden, Low Endotoxin

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

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

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Product Code: TRIS-3254 | Previously: TR3254

Intended For Use As An Excipient

Tromethamine (Tris), is commonly used as a buffer and excipient in biological applications downstream in 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: C₄H₁₁NO₃Sol. In H₂O @ 25°C (g/L): 550
F.W.: 121.14 g/mol
pH @ 20°C 5% aq.: 10.0 - 11.5
Useful pH: 7.0 - 9.0
pK_a @ 20˚C: 8.3

Product Specifications

ANALYSIS

SPECIFICATIONS (USP)

Appearance and Color

White/Crystals

Assay

99.0 – 101.0%

Endotoxin

≤ 2.5 EU/g

Identification A

Passes Test

Identification B

Passes Test

Identification C

Passes Test

Loss on Drying

≤ 1.0%

Melting Range

168 - 172ºC

pH (1 in 20)

10.0 – 11.5

Residue on Ignition

≤ 0.1%

Microbial Content

TAMC

TYMC

≤ 500 CFU/g

≤ 200 CFU/g

ANALYSIS

SPECIFICATIONS (EP)

Appearance of Solution

Passes Test

Assay

99.0-100.5%

Chloride (Cl)

≤ 100 ppm

Identification A

Passes Test

Identification B

168 - 174°C

Identification C

Passes Test

Iron (Fe)

< 10ppm

Loss on Drying at 105ºC

≤0.5%

10.0 – 11.5

Related Substances

≤ 1.0%

Sulfated Ash

≤ 0.1%

Printable Version

General Product Description:

The manufacturing of Tromethamine TRIS-3254 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
Tromethamine is a White Crystalline product
Molecular Formula: C₄H₁₁NO₃
Molecular Weight: 121.14 g/mol.
CAS Number: 77-86-1
There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
Biospectra certifies that all Tromethamine TRIS-3254 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts. Tromethamine manufactured at BioSpectra and any raw materials used in the manufacture of Tromethamine at BioSpectra are not subject to genetic modification.
Synonyms: Tris, Tromethamine, Tris (hydroxymethyl) aminomethane

GMP Compliance:

Bio Excipient Grade Tromethamine TRIS-3254 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tromethamine is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

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.

Expiration:

The recommended expiration period for Tromethamine is three years from the date of manufacture.

Storage and Shipping Conditions:

Store in a cool, dry place. Store in a cool, dry, well-ventilated area away from incompatible substances. Keep away from acids. Keep containers tightly closed.

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.