Chemical testing, parenteral drug

The most influential of these test protocols are the USP, - the European Pharmacopoeia (EP), the Pharmacopoeia of Japan (JP), - the Organization for International Standardization (ISO), and the Parenteral Drug Association (PDA). ° USP<381>, Elastomeric Closures for Injections, contains five chemical tests and two biological tests. Closures must meet the biological requirements but there are no current specifications for the chemical tests. All USP chemical tests are commonly performed on aqueous extracts but isopropyl alcohol and the drug product vehicle are also permitted. A brief description of the USP<381> tests follows. ... 

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. 

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