Tris Excipient

ICH-Q7 GMP Manufactured Product

Tris Excipient

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

*Low Bioburden, Low Endotoxin

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

Product Inquiry COAs Spec Sheet

Click the button above for additional pricing, lead times, MOQs and other inquiries.

Product Inquiry

Product(s) of Interest *

First Name *

Last Name *

Title & Position in Company *

Email *

Your Direct Phone Number & Country Code *

Name of Your Company *

Website of Your Company *

Address of Company *

Country where product is to be used *

Name of Your Customer – the End User *

Website of Your Customer – the End User *

Intended Application/Use if known

Package Size Requested *

Estimated Release Quantity per PO in Liters or Kgs *

Estimated Annual Demand in Liters or Kgs *

Regulatory or Compendial Requirements *

INCO Terms requested *

Please Use the Product Inquiry button (above) for bulk volumes.

Customer Service

First Name *

Last Name *

Company Name *

Position in Company

Email *

Company website

Company phone with country code *

Country where product is to be used *

Street Address *

City *

State *

Zip Code *

Country *

Additional Information Needed/Requested

Please Use the Product Inquiry button (above) for bulk volumes.

UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: TRIS-3251 | Previously: TR3251

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 (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 (Ultrapure, Dried Basis)

≥ 99.9%

Chloride (ChP/EP)

≤ 100 ppm

Clarity and Color of Solution (ChP/JPC)

Passes Test

Endotoxins

≤ 2.5 EU/g

Enzymes

DNase

Protease

RNase

None Detected

Heavy Metals (as Pb) (ChP/JPC)

≤ 1 ppm

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

Passes Test

Identification A (JPC)

Passes Test

Identification B (USP/ChP-1)

Passes Test

Identification B (JPC)

Passes Test

Identification C (USP)

Passes Test

Identification D (EP/ChP-2)

Passes Test

Insoluble Matter

≤ 0.005%

Karl Fischer Water

≤ 1.0%

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

≤ 0.3%

Melting Range (USP/ChP/IDB-EP/JPC)

168 - 172°C

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
≤ 100 CFU/g
Absence in 1g
Absence in 1g
Absence in 1g
Absence in 1g
Absence in 1g
Absence in 10g

pH (5%) (USP/IDA-EP/ChP)

10.0 – 11.5

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
≤ 1 ppm
≤ 1 ppm
≤ 1 ppm
≤ 5 ppm
≤ 1 ppm
≤ 15 ppm
≤ 1 ppm

Printable Version

General Product Description:

The manufacturing of Tromethamine TRIS-3251 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-3251 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, Chinese Pharmacopeia TRIS-3251 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tromethamine, Chinese Pharmacopeia 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:

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.