Tris Excipient Troethamine

Excipient

ICH-Q7 GMP Manufactured Product

TROMETHAMINE (TRIS)

USP, GMP, Excipient Grade
Product Code: TRIS-3220

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

Total

Product Code: TRIS-3220 | Previously: TR3220

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

Absorbance (40%)

290 nm

≤ 0.2 a.u.

Appearance and Color

White / Crystals

Assay

99.0–101.0%

Chloride

≤100 ppm

Enzymes

DNase

RNase

Protease

None Detected

Heavy Metals

≤ 5 ppm

Identification B

Passes Test

Identification C

Passes Test

Identification (IR)

Passes Test

Insoluble Matter

≤ 0.005%

Karl Fischer Water

≤ 2.0%

Loss on Drying

≤ 1.0%

Melting Range

168–172˚C

pH (5%)

10.0–11.5

Residue On Ignition

≤ 0.1%

Trace Metals

Arsenic (As)

Calcium (Ca)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Magnesium(Mg)

≤ 5 ppm
≤ 5 ppm
≤ 5 ppm
≤ 5 ppm
≤ 5 ppm
≤ 5 ppm

Printable Version

General Product Description:

The manufacturing of Tromethamine TRIS-3220 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-3220 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, Tri (Hydroxymethyl) Amino Methane.

GMP Compliance:

Bio Excipient Grade Tromethamine TRIS-3220 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.

Expiration:

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

Storage and Shipping Conditions:

Ship and Store in ambient temperature.

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.