Parenteral drug products release testing

One of the important requirements of any packaging material is that it should not release any component into the drug product. Preparation of containers free of any leachables such as monomeric component is especially important for the containers of ophthalmics, parenteral products, and any liquid products. It was shown that di(2-ethylhexyl) phthalate was released from the PVC bags and that caused haziness of the taxol solution (37), USP/NF offers the protocol of chemical, spectral, and water vapor permeation tests and tolerances for plastic containers (55). Among those, chemical test is designed to give a quantitative assessment of the extractable materials in both organic solvents and water. 

---