Extractable & Leachable Studies

The need for accurate and definitive Extractable & Leachable studies has intensified and should be done in compliance with USP, ICH, BPOG, PQRI and ISO 10993. We at Daicel Analytical Services are able to offer customers the most comprehensive studies for your packing materials, Manufacturing systems, Raw Materials, single use systems, devices, various finished drug products like Inhalations, Injectables, MDIs, Ophthalmic etc.,

All E&L studies by Daicel Analytical Services are conducted in our US-FDA audited analytical facility at Hyderabad, India and fully support regulatory compliance. With high ability of understand the regulatory aspects of qualifying the drug products, Daicel has started this service in 2019 and completed good number of projects so far.