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.
