Product Category

Excipient

ICH-Q7 GMP Manufactured Product

TRIS HCl
GMP Standard Excipient Grade

Product Code: THCL-3220 | Previously: TH3220

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 280nm
0.6 a.u. max.
Appearance  
Passes Test
Assay, Dried  
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  
2.0% 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 Elements 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
List of C of As files
THCL-0124-00019_THCL-3220.pdf
THCL-0123-00291_THCL-3220.pdf
THCL-0124-00008_THCL-3220.pdf
THCL-0123-00294_THCL-3220-10.pdf
THCL-0123-00292_THCL-3220.pdf
THCL-0123-00283_THCL-3220.pdf
THCL-0123-00290_THCL-3220.pdf
THCL-0123-00271_THCL-3220-12.pdf
THCL-0123-00289_THCL-3220.pdf
THCL-0123-00270_THCL-3220.pdf
THCL-0123-00264_THCL-3220.pdf
THCL-0123-00261_THCL-3220.pdf
THCL-0123-00244_THCL-3220.pdf
THCL-0123-00243_THCL-3220.pdf
THCL-0123-00235_THCL-3220.pdf
THCL-0123-00207_THCL-3220.pdf
THCL-0123-00181_THCL-3220-12.pdf
THCL-0123-00195_THCL-3220.pdf
THCL-0123-00175_THCL-3220.pdf
THCL-0123-00153_THCL-3220.pdf
THCL-0123-00129_THCL-3220.pdf
THCL-0123-00100_THCL-3220.pdf
THCL-0123-00089_THCL-3220.pdf
THCL-0123-00088_THCL-3220.pdf
THCL-0123-00083_THCL-3220.pdf
THCL-0123-00072_THCL-3220.pdf
THCL-0123-00070_THCL-3220-25.pdf
THCL-0123-00069_THCL-3220.pdf
THCL-0123-00067_THCL-3220-10.pdf
THCL-0123-00058_THCL-3220.pdf
THCL-0123-0038_THCL-3220-10.pdf
THCL-0123-0008_THCL-3220-10.pdf
THCL-0123-00018_THCL-3220-12.pdf
THCL-0123-00017_THCL-3220.pdf
THCL-0122-00322_THCL-3220-10.pdf
THCL-0122-00320_THCL-3220.pdf
THCL-0122-00340_THCL-3220.pdf
THCL-0122-00321_THCL-3220.pdf
THCL-0122-00300_THCL-3220.pdf
THCL-0122-00297_THCL-3220.pdf
THCL-0122-00256_THCL-3220.pdf
THCL-0122-00254_THCL-3220.pdf
THCL-0122-00247_THCL-3220.pdf
THCL-0122-00245_THCL-3220.pdf
THCL-0122-00232_THCL-3220.pdf
THCL-0122-00206_THCL-3220.pdf
THCL-0122-00194_THCL-3220.pdf
THCL-0122-00186_THCL-3220.pdf
THCL-0122-00179_THCL-3220.pdf
THCL-0122-00178_THCL-3220.pdf
THCL-0122-00177_THCL-3220.pdf
THCL-0122-00171_THCL-3220.pdf
THCL-0122-00167_THCL-3220.pdf
THCL-0122-00166_THCL-3220.pdf
THCL-0122-00165_THCL-3220 500g.pdf
THCL-0122-00165_THCL_3220 50kg.pdf
THCL-0122-00163_THCL-3220.pdf
THCL-0122-00158_THCL-3220.pdf
THCL-0122-00156_THCL-3220.pdf
THCL-0122-00155_THCL-3220.pdf
THCL-0122-00154_THCL-3220.pdf
THCL-0221-00078_THCL-3220.pdf
THCL-0221-00022_THCL-3220.pdf
THCL-0122-00137_THCL-3220.pdf
THCL-0122-00131_THCL-3220.pdf
THCL-0122-00101_THCL-3220.pdf
THCL-0122-00095_THCL-3220.pdf
THCL-0122-00077_THCL-3220.pdf
THCL-0122-00067_THCL-3220.pdf
THCL-0122-00065_THCL-3220.pdf
THCL-0122-00063_THCL-3220.pdf
THCL-0122-00041_THCL-3220.pdf
THCL-0122-00047_THCL-3220.pdf
THCL-0122-00039_THCL-3220.pdf
THCL-0122-00027_THCL-3220.pdf
THCL-0122-00019_THCL-3220.pdf
THCL-0121-00165_THCL-3220.pdf
THCL-0122-00018_THCL-3220.pdf
THCL-0121-00251_THCL-3220-12.pdf
THCL-0121-00236_THCL-3220.pdf
THCL-0121-00235_THCL-3220.pdf
THCL-0121-00188_THCL-3220.pdf
THCL-0121-00186_THCL-3220.pdf
THCL-0121-00184_THCL-3220.pdf
THCL-0121-00183_THCL-3220.pdf
THCL-0121-00174_THCL-3220.pdf
THCL-0121-00174_THCL-3220 (2).pdf
THCL-0121-00173_THCL-3220.pdf
THCL-0121-00173_THCL-3220 (2).pdf
THCL-0121-00166_THCL-3220.pdf
THCL-0121-00177_THCL-3220.pdf
THCL-0121-00138_THCL-3220.pdf
THCL-0121-00119_THCL-3220.pdf
THCL-0121-00120_THCL-3220.pdf
THCL-0121-00121_THCL-3220.pdf
THCL-0121-00094_THCL-3220.pdf
THCL-0121-00095_THCL-3220.pdf
THCL-0121-00044_THCL-3220.pdf
THCL-0121-00045_THCL-3220.pdf
THCL-0121-00030_THCL-3220.pdf
THCL-0121-00043_THCL-3220.pdf
THCL-0121-00023_THCL-3220.pdf
THCL-0121-0158_THCL-3220.pdf
THCL-0121-00054_THCL-3220.pdf
THCL-0121-0199_THCL-3220.pdf
THCL-0121-0267_THCL-3220.pdf
THCL-0121-0198_THCL-3220.pdf
THCL-0121-0197_THCL-3220.pdf
THCL-0121-0189_THCL-3220.pdf
THCL-0121-0088_THCL-3220.pdf
TH3220-146-0221.pdf
TH3220-145-0221.pdf
TH3220-144-0121.pdf
TH3220-143-0121.pdf
TH3220-141-1220.pdf
TH3220-140-1120.pdf
TH3220-138-1120.pdf
TH3220-137-1120.pdf
TH3220-136-1020.pdf
TH3220-135-1020.pdf
TH3220-134-0920.pdf
TH3220-133-0920.pdf
TH3220-132-0820.pdf
TH3220-131-0820.pdf
TH3220-130-0820.pdf
TH3220-129-0720.pdf
TH3220-128-0720.pdf
TH3220-127-0720.pdf
TH3220-121-0520.pdf
TH3220-119-0420.pdf
TH3220-116-0420.pdf
TH3220-126-0620.pdf
TH3220-125-0520.pdf
TH3220-124-0520.pdf
TH3220-122-0520.pdf
TH3220-123-0520.pdf
TH3220-120-0420.pdf
TH3220-118-0420.pdf
TH3220-117-0420.pdf
TH3220-113-0320.pdf
TH3220-112-0320.pdf
TH3220-114-0320.pdf
TH3220-115-0320.pdf
TH3220-111-0320.pdf
TH3220-110-0220.pdf
TH3220-109-0220.pdf
TH3220-108-0220.pdf
TH3220-107-0220.pdf
TH3220-106-0120.pdf
TH3220-105-0120.pdf
TH3220-101-1219.pdf
TH3220-104-1219.pdf
TH3220-103-1219.pdf
TH3220-102-1219.pdf
TH3220-100-1119.pdf
TH3220-099-1119.pdf
TH3220-098-1119.pdf
TH3220-096-1019.pdf
TH3220-097-1019.pdf
TH3220-095-0919.pdf
TH3220-093-0919.pdf
TH3220-094-0919.pdf
TH3220-070-1218.pdf
TH3220-092-0919.pdf
TH3220-091-0819.pdf
TH3220-090-0719.pdf
TH3220-089-0719.pdf
TH3220-088-0719.pdf
TH3220-086-0619.pdf
TH3220-087-0719.pdf
TH3220-085-0619.pdf
TH3220-084-0519.pdf
TH3220-083-0519.pdf
TH3220-082-0519.pdf
TH3220-081-0519.pdf
TH3220-080-0519.pdf
TH3220-079-0519.pdf
TH3220-078-0519.pdf
TH3220-077-0319.pdf
TH3220-076-0319.pdf
TH3220-075-0319.pdf
TH3220-074-0319.pdf
TH3220-073-0219.pdf
TH3220-072-0119.pdf
TH3220-065-1118.pdf
TH3220-064-1018.pdf
TH3220-063-1018.pdf
TH3220-062-1018.pdf
TH3220-071-1218.pdf
TH3220-069-1118.pdf
TH3220-068-1118.pdf
TH3220-067-1118.pdf
TH3220-066-1118.pdf
TH3220-059-0918.pdf
TH3220-058-0918.pdf
TH3220-060-0918.pdf
TH3220-061-0918.pdf
TH3220-057-0818.pdf

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General Product Description:

  • The manufacturing of Tris Hydrochloride THCL-3220 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: 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-3220 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-3220 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.

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.

Package Sizes:

10kg, 25kg and 50kg pails.

Additional Packaging Information

https://www.biospectra.us/technical/packaging

COAs and Tech Docs

Product-image
formula-image

THCL-3220 | TH3220

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