Research Project
9568962
The Contract will manufacture a batch of 2000 vials Triapine Injection 5 mg/mL at, 10 mL/ Vial using the following procedure: Triapine Injection formulation: Each 10mL vial contains 50 mg of Triapine (i.e., 5 mg/mL), 60 mg of citric acid, anhydrous, 10 mg of L-ascorbic acid, 3 mL of ethyl alcohol, and 7 mL of polyethylene glycol 300. This formulation will provide 10 mL of a clear yellowish slightly viscous, sterile, non-aqueous solution for IV administration. The container closure: Use siliconized amber vials, suitable to hold 10 mL, and close with PTFE-coated rubber stopper and seal with an aluminum crimp. It is important to note that the solubility of API in PEG 300 is about 15 mg/mL and in Ethanol is around 1.2 mg/ml. A limited development work is, therefore, allowed. To determine the material is completely dissolved in the vehicle. After QC/QA release label the product and ship the manufactured product to our clinical repository and shelf life contractor.
