Publications by authors named "Kavita Inamdar"
J Pharm Sci
December 2024
Article Synopsis
- LDPE bottles were selected as the container closure system for packaging Latanoprost ophthalmic solution, with an alternative manufacturer also providing similar bottles for evaluation.
- An extractables and leachable (E&L) study along with a stability program assessed the quality of the solution in both sets of bottles, revealing an unknown impurity in one batch.
- Further investigation identified the impurity as Epsilon-caprolactam, a leachable from the transportation packaging, highlighting the need to consider the entire supply chain in leachability assessments.
