Bio Excipient Grade Tromethamine, TR3251 is manufactured in accordance with ICH Q7 compliant cGMP guidelines and is suitable for use “downstream” in the manufacture of drug products including use in further manufacturing of parenteral grade products. This grade of Tromethamine is not sterile and requires terminal sterilization. It is not intended for use as an API, final Drug Product or Household item.
The recommended retest period for Tromethamine is two years from the date of manufacture.
Storage and Shipping Conditions:
Store in a cool, dry place. Store in a cool, dry, well-ventilated area away from incompatible substances. Keep away from acids. Keep containers tightly closed.
10kg, 25kg and 50kg pails.
Residual Solvents Statement:
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 Tables 1, 2, 3, or 4.