Answer Posted / Rohit Singh Yadav
Extractables and leachables are potential contaminants in pharmaceutical products that may be released from the product's container, packaging materials, or excipients during manufacturing, storage, or administration. An extractable study identifies substances that can be extracted from the material by using a solvent under specific conditions. A leachable study determines if any of these identified extractables migrate into the drug substance or final product under normal use conditions.
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