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Product Category

Excipient

ICH-Q7 GMP Manufactured Product

TRIS HCl, LBLE, LEI, High Assay,
GMP Excipient Grade

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: THCL-3260

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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.

Product Specifications

ANALYSIS

SPECIFICATIONS
Absorbance (1M)

260nm

280nm

400nm

≤ 0.06 a.u.

≤ 0.06 a.u.

≤ 0.01 a.u.
Appearance and Color  
White / Crystals
Assay, Dried  
99.5% min.
Bioburden ≤ 100 CFU/g
Endotoxin ≤ 2.5 EU/g
Enzymes

DNase

RNase

Protease

None Detected

None Detected

None Detected
Heavy Metals  
2 ppm max.
Identification

(IR)

(Chloride)

Passes Test

Passes Test
Loss on Drying @ 105°C  
≤ 0.5%
Melting Range  
150–152 ºC
pH

(1% Aqueous Solution)

(0.5M) @ 25°C

4.0-5.0

3.5-5.0
Residue on Ignition 0.1% max.
Solubility 35%  
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.

Water (Karl Fischer)

0.5% max.

Printable Version

List of C of As files
THCL-0122-00298_THCL-3260.pdf
THCL-0122-00274_THCL-3260.pdf
THCL-0122-00272_THCL-3260.pdf
THCL-0122-00134_THCL-3260.pdf
THCL-0122-00133_THCL-3260.pdf
THCL-0122-00132_THCL-3260.pdf
THCL-0221-00252_THCL-3260.pdf

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General Product Description:

  • The manufacturing of Tris Hydrochloride THCL-3260 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
  • Tris Hydrochloride 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 THCL-3260 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 Hydrochloride, 2-Amino-2-(Hydroxymethyl)- 1,3-Propanediol Hydrochloride; Tris (Hydroxymethyl) Aminomethane Hydrochloride


GMP Compliance:

Bio Excipient Grade Tris Hydrochloride THCL-3260 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 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.

Additional Packaging Information

https://www.biospectra.us/technical/packaging
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COAs and Tech Docs

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formula-image

THCL-3260 | TH3260

CAS #: 1185-53-1

Formula: C4H11NO3·HCl

Sol. In H2O (g/L): 1,010

F.W.: 157.60 g/mol

pH @ 20°C: 4.5-6.0

Useful pH: 7.0-9.0

pKa @ 20˚C: 8.2