Excipient
ICH-Q7 GMP Manufactured ProductTRIS HCl, LBLE, LEI, Low S.A. (EP)
Low Bioburden, Low Endotoxin, GMP Manufactured
Product Code: THCL-3259 | Previously: TH3259
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
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ANALYSIS |
SPECIFICATIONS |
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≤ 0.06 a.u. ≤ 0.06 a.u. ≤ 0.01 a.u. |
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White / Crystals | ||
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≥ 99.5% - 101% | ||
| Bioburden | ≤ 100 CFU/g | ||
| Endotoxin | ≤ 2.5 EU/g | ||
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None None None |
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2 ppm max. | ||
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Passes Test Passes Test |
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0.001% max. | ||
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≤ 0.5% | ||
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150–152ºC | ||
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4.0-5.0 3.5-5.0 |
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8.0 – 8.4 | ||
| Residue on Ignition | 0.1% max. | ||
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Passes Test | ||
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≤ 300 ppm | ||
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1 ppm max. |
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Water (Karl Fischer) |
≤ 0.5% |
| Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH-Q7 Compliant Manufactured | ||
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| indicates an attribute or level of compliance which is granted or available based on the purchase of the product grade. |
| Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient |
| LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin). LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Elemental Impurities
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- REACH
- Prop 65
- Stability Data Statement
- Imidazole
- TUPP
- Formaldehyde
- Slip Agent Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
- Stability Report
- Nitrosamine Risk Assessment
- Label Copy
- IR Spectra
THCL-3259 | TH3259
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
General Product Description:
- The manufacturing of Tris Hydrochloride THCL-3259 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-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 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-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 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.
Retest Date:
The recommended retest period for Tromethamine Hydrochloride is two 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