Product Category

Excipient

ICH-Q7 GMP Manufactured Product

TRIS HCl, LBLE,
GMP Standard Excipient Grade

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: THCL-3250 | Previously: TH3250

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  
Passes Test
Assay, Dried  
≥ 99.0%
Bioburden ≤ 100 CFU/g 
Endotoxin ≤ 2.5 EU/g
Enzymes

DNase
RNase
Protease

None
None
None
Identification

(IR)

(Chloride)

Passes Test

Passes Test

Loss on Drying @ 105°C  
≤ 0.5%
Melting Range  
147–152ºC
pH

(1% Aqueous Solution)

(0.5M) @ 25°C 

4.0-5.0

3.5-5.0

Trace Metals

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

≤ 10 ppm 
≤ 10 ppm
≤ 10 ppm
≤ 10 ppm
≤ 10 ppm
≤ 10 ppm

Water

≤ 2.0%

Printable Version

List of C of As files
THCL-0124-00028_THCL-3250.pdf
THCL-0123-00265_THCL-3250.pdf
THCL-0124-00032_THCL-3250.pdf
THCL-0124-00015_THCL-3250.pdf
THCL-0124-00018_THCL-3250.pdf
THCL-0124-00012_THCL-3250.pdf
THCL-0124-00009_THCL-3250.pdf
THCL-0124-00004_THCL-3250.pdf
THCL-0123-00285_THCL-3250.pdf
THCL-0123-00284_THCL-3250.pdf
THCL-0123-00288_THCL-3250.pdf
THCL-0123-00273_THCL-3250.pdf
THCL-0123-00265_THCL-3250-58.pdf
THCL-0123-00260_THCL-3250.pdf
THCL-0123-00255_THCL-3250.pdf
THCL-0123-00225_THCL-3250.pdf
THCL-0123-00242_THCL-3250.pdf
THCL-0123-00236_THCL-3250.pdf
THCL-0223-00205_THCL-3250.pdf
THCL-0123-00216_THCL-3250.pdf
THCL-0123-00213_THCL-3250.pdf
THCL-0123-00196_THCL-3250.pdf
THCL-0123-00180_THCL-3250-25.pdf
THCL-0123-00160_THCL-3250-25.pdf
THCL-0123-00154_THCL-3250-12.pdf
THCL-0123-00151_THCL-3250.pdf
THCL-0123-00144_THCL-3250-58.pdf
THCL-0123-00143_THCL-3250.pdf
THCL-0123-00150_THCL-3250.pdf
THCL-0123-00152_THCL-3250.pdf
THCL-0123-00149_THCL-3250.pdf
THCL-0123-00136_THCL-3250.pdf
THCL-0123-00128_THCL-3250-12.pdf
THCL-0123-00127_THCL-3250-12.pdf
THCL-0123-00071_THCL-3250-12.pdf
THCL-0123-00068_THCL-3250-58.pdf
THCL-0123-00046_THCL-3250-12.pdf
THCL-0123-00029_THCL-3250-58.pdf
THCL-0123-00032_THCL-3250-58.pdf
THCL-0123-00022_THCL-3250.pdf
THCL-0123-00024_THCL-3250.pdf
THCL-0123-00023_THCL-3250.pdf
TH3250-037-0221_THCL-3250-5.pdf
TH3250-033-0121_THCL-3250-25.pdf
THCL-0121-0002_THCL-3250-25.pdf
THCL-0121-0001_THCL-3250-25.pdf
THCL-0122-00318_THCL-3250.pdf
THCL-0122-00319_THCL-3250.pdf
THCL-0122-00333_THCL-3250.pdf
THCL-0122-00313_THCL-3250.pdf
THCL-0122-00264_THCL-3250.pdf
THCL-0122-00263_THCL-3250.pdf
THCL-0122-00262_THCL-3250.pdf
THCL-0122-00261_THCL-3250.pdf
THCL-0122-00260_THCL-3250.pdf
THCL-0122-00259_THCL-3250.pdf
THCL-0122-00250_THCL-3250.pdf
THCL-0122-00249_THCL-3250.pdf
THCL-0122-00248_THCL-3250.pdf
THCL-0122-00224_THCL-3250.pdf
THCL-0122-00191_THCL-3250.pdf
THCL-0122-00192_THCL-3250.pdf
THCL-0222-00184_THCL-3250.pdf
THCL-0122-00185_THCL-3250.pdf
THCL-0122-00172_THCL-3250.pdf
THCL-0122-00157_THCL-3250.pdf
THCL-0222-00153_THCL-3250.pdf
THCL-0122-00126_THCL-3250.pdf
THCL-0122-00124_THCL-3250.pdf
THCL-0122-00127_THCL-3250.pdf
THCL-0122-00122_THCL-3250.pdf
THCL-0122-00121_THCL-3250.pdf
THCL-0122-00120_THCL-3250.pdf
THCL-0122-00119_THCL-3250.pdf
THCL-0122-00118_THCL-3250.pdf
THCL-0122-00111_THCL-3250.pdf
THCL-0122-00110_THCL-3250.pdf
THCL-0122-00125_THCL-3250.pdf
THCL-0122-00109_THCL-3250.pdf
THCL-0122-00099_THCL-3250.pdf
THCL-0122-00093_THCL-3250.pdf
THCL-0122-00100_THCL-3250.pdf
THCL-0122-00097_THCL-3250.pdf
THCL-0122-00084_THCL-3250.pdf
THCL-0122-00082_THCL-3250.pdf
THCL-0122-00081_THCL-3250.pdf
THCL-0222-00031_THCL-3250.pdf
THCL-0122-00029_THCL-3250.pdf
THCL-0122-00030_THCL-3250.pdf
THCL-0122-00026_THCL-3250.pdf
THCL-0122-00011_THCL-3250.pdf
THCL-0221-00233_THCL-3250.pdf
THCL-0122-00008_THCL-3250-10.pdf
THCL-0121-00249_THCL-3250.pdf
THCL-0121-00248_THCL-3250.pdf
THCL-0121-00247_THCL-3250.pdf
THCL-0121-00244_THCL-3250.pdf
THCL-0121-00224_THCL-3250.pdf
THCL-0121-00223_THCL-3250.pdf
THCL-0121-00222_THCL-3250.pdf
THCL-0121-00221_THCL-3250.pdf
THCL-0121-00187_THCL-3250.pdf
THCL-0121-00157_THCL-3250.pdf
THCL-0121-00140_THCL-3250.pdf
THCL-0121-00137_THCL-3250.pdf
THCL-0121-00125_THCL-3250.pdf
THCL-0121-00124_THCL-3250.pdf
THCL-0121-00123_THCL-3250.pdf
THCL-0121-00122_THCL-3250.pdf
THCL-0121-00112_THCL-3250.pdf
THCL-0121-00081_THCL-3250.pdf
THCL-0121-00064_THCL-3250.pdf
THCL-0121-00047_THCL-3250.pdf
THCL-0121-0001_THCL-3250.pdf
THCL-0121-0222_THCL-3250.pdf
THCL-0121-00002_THCL-3250.pdf
THCL-0121-0002_THCL-3250.pdf
THCL-0121-0086_THCL-3250.pdf
TH3250-037-0221.pdf
TH3250-034-0221.pdf
TH3250-035-0221.pdf
TH3250-036-0221.pdf
TH3250-033-0121.pdf
TH3250-031-1220.pdf
TH3250-030-1120.pdf
TH3250-028-0920.pdf
TH3250-027-0920.pdf
TH3250-026-0920.pdf
TH3250-025-0820.pdf
TH3250-024-0820.pdf
TH3250-023-0820.pdf
TH3250-022-0720.pdf
TH3250-021-0520.pdf
TH3250-020-0520.pdf
TH3250-019-0320.pdf
TH3250-018-1219.pdf
TH3250-017-1219.pdf

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General Product Description:

  • The manufacturing of Tris Hydrochloride THCL-3250 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-3250 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-3250 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

COAs and Tech Docs

Product-image
formula-image

THCL-3250 | TH3250

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