TRIS HCl - Excipient

BIO EXCIPIENT GRADE | TH3220 | CAS# 1185-53-1

INTENDED FOR USE AS AN EXCIPIENT

Tris Hydrochloride is a stabilizing buffer in biological
applications such as electrochromatography, UV analysis
and HPLC. It is used to adjust and stabilize the pH ranges
for gels used in electrophoresis applications. Tris
Hydrochloride is extensively used as a biological buffer
or a component of buffer solutions.

These are general specifications. BioSpectra will customize our products to meet your quality based requirements.

BIO EXCIPIENT GRADE / TH3220

CAS #: 1185-53-1

Molecular Formula:

C₄H₁₁NO₃HCl

Solubility in Water (g/L): 1010

F.W.: 157.60 g/mol

pH @ 20°C: 4.5 - 6.0

Useful pH: 7.0 - 9.0

pKa @ 20˚C: 8.2

SDS
Spec Sheet
Compliance
C of As

ANALYSIS

SPECIFICATIONS

Absorbance

280 nm

0.6 a.u. max.

Appearance and Color

White / Crystals

Assay

99.5% min.

Enzymes

DNase

RNase
Protease

None Detected
None Detected
None Detected

Heavy Metals

2 ppm max.

Identification (IR)

Passes Test

Insoluble Matter

0.001% max.

Karl Fischer

0.5% max.

Melting Range

150 – 153 ˚C

pH(0.5M)

4.0 – 5.0

pKa

8.0 – 8.4

Residue on Ignition

0.1% max.

Solubility

Passes Test

Trace Metals

Arsenic (As)
Calcium (Ca),
Copper (Cu)
Iron (Fe)
Lead (Pb)
Magnesium(Mg)

1 ppm max.
1 ppm max.
1 ppm max.
1 ppm max.
1 ppm max.
1 ppm max.

Printable Version

Key Compliance Attributes of BioSpectra Grades

Bio Excipient Grade ICH Q7 Compliant Manufactured

Suitable for Research and Diagnostic

Yes

Each Batch 100% Analyzed

Yes

Management of Change

Yes

Validated Analytical Methods

Yes

Compendial Testing

Yes

Trace Metals Analyzed

Yes

Two Year Stability

Yes

BioSpectra Supply Chain Audit Trail

Yes

Product Origin Statement

Yes

Customer Quality Audits

Yes

Customized Additional Specifications

Yes

Multi-Compendial Testing

Yes

Enzyme Tested

Yes

Validated Manufacturing Process

Yes

US Manufactured at BioSpectra

Yes

IPEC cGMP Compliant Manufactured

Yes

Suitable for use as Excipient

Yes

Microbial / Endotoxin Tested

Yes

Manufactured in FDA Registered Facility

Available

Customized Manufacturing Schedule

Available

Custom Regulatory Packet

Available

Accelerated Stability

Available

Type IV Drug Master File

Available

Video Conference access to BioSpectra Sites

Available

Complete access to Product Traceability

Available

Access to Supply Chain Information

Yes

ICH Q7 Qualified Utilities

Yes

ICH Q7 Compliant Manufactured

Yes

Find your C of As

General Product Description:

The manufacturing of Tris Hydrochloride TH3220 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
Tris HCl is a White Crystalline product.
Molecular Formula: NH₂C(CH₂OH)₃
Molecular Weight: 157.60 g/mol.
CAS Number: 1185-53-1.
There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
BioSpectra certifies that all Tris Hydrochloride TH3220 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
Tris Hydrochloride manufactured at BioSpectra and any raw materials used in the manufacture of Tris Hydrochloride at BioSpectra are not subject to genetic modification.
Synonyms: Tris, Tromethamine, Tri (Hydroxymethyl) Amino Methane Hydrochloride.

GMP Compliance:

Bio Excipient Grade Tris Hydrochloride TH3220 is manufactured in
accordance with cGMP guidelines and is suitable to be used only
as the following: ICH Q7 Compliant cGMP Manufactured Excipient,
for use in further Manufacturing. This Grade of Tromethamine is
not suitable to be used as an Active Pharmaceutical Ingredient,
Drug, Drug Product or Household Item.

Expiration/Retest Date:

The recommended retest period for Tromethamine is two years
from the date of manufacture.

Storage and Shipping Conditions:

Ship and Store in ambient temperature.

Package Sizes:

10kg, 25kg and 50kg pails.