Our team has expertise supporting a range of products and delivery systems, including LDPE ampoules, PVC blister packs, injectables, medical devices, IV bags, ophthalmic products, and single-use systems (SUS).
Leachable and extractable impurities may be volatile organic compounds, semi-volatile organic compounds, non-volatile organic compounds, or elemental impurities. We have the appropriate instrumentation to identify and quantify all these types of compounds.
We utilize a three-phase, systematic approach that includes control extraction studies, model extraction studies, and leachable studies. We isolate, identify, and quantify individual leachable and extractable compounds. We can also perform routine container/closure testing and formulation compatibility and stability studies.
Nitto Avecia Pharma Services has more than 50 years of combined experience with polymers, metals, and pharmaceutical products to assist in identifying impurities that result from extractables and leachables in your drug products. Let us leverage this expertise to achieve your project’s success.
10 Vanderbilt Avenue
Irvine, CA 92618
Tel: (949)-951-4425
Fax: (949) 951-4909
6 Vanderbilt Avenue
Irvine, CA 92618
4 Chrysler
Irvine, CA 92618
