Bio Excipient Grade Tris Hydrochloride TH3250 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. This Grade of Tris Hydrochloride is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
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.
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.
10kg, 25kg and 50kg drums.