{"id":"W4414580177","doi":"10.1021/acsomega.4c10834","title":"Quality-by-Design-Driven RP-HPLC Method Development and Validation for Impurity Analysis of Elexacaftor, a Cystic Fibrosis Drug, with LC-MS/MS-Based Degradant Identification","year":2025,"lang":"en","type":"article","venue":"ACS Omega","topic":"Cystic Fibrosis Research Advances","field":"Medicine","cited_by":3,"is_retracted":false,"has_abstract":true,"ca_institutions":"Purdue Pharma (Canada)","funders":"","keywords":"Impurity; Forced degradation; Elution; Analytical Chemistry (journal); Detection limit; High-performance liquid chromatography; Gradient elution; Pharmaceutical formulation","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.008586911,0.001380222,0.001114964,0.00140311,0.0007528745,0.00117457,0.001071206,0.001264225,0.001012005],"category_scores_gemma":[0.00568033,0.000663078,0.001214528,0.0007305427,0.001198777,0.0007114063,0.0009774351,0.001602451,0.0008845469],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0008533786,"about_ca_system_score_gemma":0.003112241,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0008842166,"about_ca_topic_score_gemma":0.001579889,"domain_scores_codex":[0.9934769,0.001164039,0.0005252858,0.00101372,0.003515828,0.0003041811],"domain_scores_gemma":[0.9975294,0.0004230273,0.0004421836,0.0002030313,0.001309811,0.00009252573],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"bench_or_experimental","study_design_scores_codex":[0.000322222,0.0002473591,0.001662265,0.0006155904,0.0001503641,0.0002607301,0.000121033,0.001498058,0.9519298,0.0009721356,0.0005608755,0.04165968],"study_design_scores_gemma":[0.00008105639,0.001305421,0.003555611,0.00007271519,0.000151945,0.0008992418,0.00003912431,0.01554186,0.9680997,0.0004471613,0.009722335,0.00008383542],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"methods","genre_gemma":"methods","genre_scores_codex":[0.1295429,0.004279014,0.8561042,0.0003291241,0.0002399133,0.003428308,0.0008414396,0.002408863,0.002826273],"genre_scores_gemma":[0.2888041,0.003406578,0.6948824,0.001149976,0.0001295119,0.004490442,0.002311963,0.0005395986,0.004285424],"genre_candidate":"methods","genre_consensus":"methods","teacher_disagreement_score":0.008586911,"threshold_uncertainty_score":0.04541248,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.02831580635329012,"score_gpt":0.3699357388240723,"score_spread":0.3416199324707822,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}