Strategy for identification of leachables in packaged pharmaceutical liquid formulations

Impact of Sample Preparation on Dissolution Testing: Drug Binding and Extractable Impurities and Their Effect on Dissolution Data

“…Extractables from syringe filters is another factor that can affect downstream analysis of samples (7). The presence of extractables in a syringe filter introduces impurities in the sample.…”

A critical review on the use of modern sophisticated hyphenated tools in the characterization of impurities and degradation products

“…Also there exists an example of recall of nelfinavir mesylate product from the market due to conversion of mesylate to ethyl methane sulfonate, a GTI, owing to interaction with residual ethanol that was used for cleaning manufacturing surfaces [41]. A report is available where varnish applied to label migrated into the container resulting in the presence of a leachable in the product [42]. Another interesting case is that of 1,3-diphenylguanidine, which ingressed into the sample for analysis from the safety filler of the pipette bulb used to transfer liquid during sample preparation [43].…”

“…Studies were then conducted using EI-GC-MS to obtain its EI mass spectrum. The same was compared with a standard reference spectrum in NIST database and finally the product was characterized as monomethyl derivative of mephenesin [42].…”

Identification of Pharmaceutical Impurities in Formulated Dosage Forms

“…The impacts of leachables and extractables on pharmaceutical products have been reported in the literature. [73][74][75][76][77] Metal oxides are the major leachable components from glass, whereas manganese and iron can leach from amber glass vials. Organic leachables and extractables come from package materials, 73,75 plastic materials, 74 and container/closure.…”