TRIS HCl

Product Specifications

ANALYSIS

SPECIFICATIONS

Absorbance (1M)

260nm

280nm

400nm

≤ 0.06 a.u.

≤ 0.01 a.u.

Appearance and Color

White / Crystals

Assay, Dried

99.5% - 101%

Bioburden

≤ 100 CFU/g

Endotoxin

≤ 2.5 EU/g

Enzymes

DNase

RNase

Protease

None

Heavy Metals

2 ppm max.

Identification

(IR)

(Chloride)

Passes Test

Insoluble Matter

0.001% max.

Loss on Drying @ 105°C

≤ 0.5%

Melting Range

150–152ºC

pH	(1% Aqueous Solution) (0.5M) @ 25°C

4.0-5.0

3.5-5.0

pK_a

8.0 – 8.4

Residue on Ignition

0.1% max.

Solubility 35%

Passes Test

Sulfated Ash (Ph. Eur. 2.4.14)

≤ 300 ppm

Trace Metals

Arsenic (As)
Cadmium (Cd)
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.
1 ppm max.

Water (Karl Fischer)

≤ 0.5%

Printable Version

General Product Description:

The manufacturing of Tris Hydrochloride (HCl) Buffer THCL-3259 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
Tris Hydrochloride (HCl) Buffer is a White Crystalline product
Molecular Formula: C₄H₁₁NO₃ • HCI
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 (HCl) Buffer THCL-3259 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
Tris Hydrochloride (HCl) Buffer manufactured at BioSpectra and any raw materials used in the manufacture of Tris Hydrochloride at BioSpectra are not subject to genetic modification.
Synonyms: Tris Hydrochloride (HCl) Buffer, 2-Amino-2-(Hydroxymethyl)- 1,3-Propanediol Hydrochloride; Tris (Hydroxymethyl) Aminomethane Hydrochloride

GMP Compliance:

Bio Excipient Grade Tris Hydrochloride (HCl) Buffer THCL-3259 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Tris Hydrochloride (HCl) Buffer is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Product Statements:

RESIDUAL SOLVENTS: 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 Hydrochloride is three years from the date of manufacture.

Storage and Shipping Conditions:

Ship and store in ambient temperature. Store in a clean and dry area. Store in the original container.

Package Sizes:

10kg, 25kg and 50kg drums.

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.