Excipient
ICH-Q7 GMP Manufactured ProductTRIS 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
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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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Passes Test | ||
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≥ 99.0% | ||
| Bioburden | ≤ 100 CFU/g | ||
| Endotoxin | ≤ 2.5 EU/g | ||
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None None None |
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Passes Test Passes Test |
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≤ 0.5% | ||
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147–152ºC | ||
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4.0-5.0 3.5-5.0 |
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≤ 10 ppm |
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Water |
≤ 2.0% |
| 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. |
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
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Elemental Impurities
- TUPP Report - Stroudsburg
- Test Methods
- Stability Report
- Antiblock Additive Statement
- Nitrosamine Report
- Nitrosamine Risk Assessment
- Elemental Impurity Assessment
- Label Copy
- IR Spectra
- Latex Statement
- Regulatory Packet – Stroudsburg
- Regulatory Packet – Bangor
- Allergen Statement Bangor
- Allergen Statement Stroudsburg
- Animal Origin Statement Bangor
- Animal Origin Statement Stroudsburg
- BSE / TSE Statement Bangor
- BSE / TSE Statement Stroudsburg
- Catalysts Statement Bangor
- Catalysts Statement Stroudsburg
- Certificate of Origin Statement Bangor
- Certificate of Origin Statement Stroudsburg
- Formaldehyde Statement Bangor
- Formaldehyde Statement Stroudsburg
- Genotoxic Impurity Statement Bangor
- Genotoxic Impurity Statement Stroudsburg
- Gluten Free Statement Bangor
- Gluten Free Statement Stroudsburg
- GMO Statement Bangor
- GMO Statement Stroudsburg
- GMP Statement Bangor
- GMP Statement Stroudsburg
- Imidazole Statement Bangor
- Imidazole Statement Stroudsburg
- Ingredient Declaration Bangor
- Ingredient Declaration Stroudsburg
- IRGAFOS Bangor
- IRGAFOS Stroudsburg
- Melamine Bangor
- Melamine Stroudsburg
- Mycotoxin-Aflatoxin Statement Bangor
- Mycotoxin-Aflatoxin Statement Stroudsburg
- Nitrosamine Risk Assessment Bangor
- Nitrosamine Risk Assessment Stroudsburg
- Phthalate, Bisphenol, Dioxin Bangor
- Phthalate, Bisphenol, Dioxin Stroudsburg
- Process Flow Diagram Bangor
- Process Flow Diagram Stroudsburg
- Prop 65 Bangor
- Prop 65 Stroudsburg
- REACH Bangor
- REACH Stroudsburg
- Residual Solvents Bangor
- Residual Solvents Stroudsburg
- Slip Agent Statement Bangor
- Slip Agent Statement Stroudsburg
- Supply Chain Statement Bangor
- Supply Chain Statement Stroudsburg
- Compliance Statement Bangor
- Compliance Statement Stroudsburg
- TUPP Bangor
- M11 TUPP Report Bangor
- Elemental Impurity Assessment Bangor (M11)
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