Optimizing neutralization strategies for microbial testing of non-sterile pharmaceutical finished products with challenging method suitability

Our results provide detailed protocols that can help guide method suitability testing of finished pharmaceutical products for which neutralization proves challenging. We also include testing for B. cepacia complex in aqueous dosage form, often overlooked in the QC process. Since the current QC practice mostly assumes that these products do not require further testing, similar studies are especially needed to ensure the safety of finished pharmaceutical products during marketing, storage, and use.