Revealing the Stable δ²H, δ¹³C, and δ¹⁸O Isotopic Patterns of Ibuprofen Drug Products and Commonly Used Pharmaceutical Excipients.

ABSTRACT: This study explored the use of stable light δ²H, δ¹³C, and δ¹⁸O isotope ratio mass spectrometry (IRMS) to identify unique isotopic signatures in 27 ibuprofen drug products and pharmaceutical 27 commonly used excipients. The 27 ibuprofen drug products were collected from six different countries containing active pharmaceutical ingredient varying from 20% to 82% of the total tablet mass and 6-18 excipients. The drug products were homogenized by ball milling, but no other sample preparation was required prior to analysis. Approximately 150 μg of sample material was encapsulated (n = 3) and analyzed through TC/EA IRMS calibrated against certified reference materials. The isotopic analyses were conducted over consecutive weeks with high data reproducibili

SUBMITTER: Holmfred E 

PROVIDER: S-EPMC12326347 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature