Development and validation of a headspace GC-MS method to evaluate the interconversion of impurities and the product quality of liquid hand sanitizers.

Abrigo, Nicolas; Ruzicka, Connie; Faustino, Patrick; Stiber, Neil; NguyenPho, Agnes; O'Connor, Thomas; Shakleya, Diaa

Abrigo, Nicolas; Ruzicka, Connie; Faustino, Patrick; Stiber, Neil; NguyenPho, Agnes; O'Connor, Thomas; Shakleya, Diaa.

Afiliación

Abrigo N; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Life Sciences Building 64, Silver Spring, MD 20993 USA.
Ruzicka C; Division of Pharmaceutical Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, U.S. Food and Drug Administration, 645 S Newstead Ave., St. Louis, MO 63110 USA.
Faustino P; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Life Sciences Building 64, Silver Spring, MD 20993 USA.
Stiber N; Division of Quality Intelligence II, Office of Quality Surveillance, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993 USA.
NguyenPho A; Division of Quality Intelligence II, Office of Quality Surveillance, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993 USA.
O'Connor T; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Life Sciences Building 64, Silver Spring, MD 20993 USA.
Shakleya D; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Life Sciences Building 64, Silver Spring, MD 20993 USA.

AAPS Open ; 8(1): 1, 2022.

Article en En | MEDLINE | ID: mdl-35071739