Mass Balance in Pharmaceutical Stress Testing: A Review of Principles and Practical Applications.

Autor: Marden S; Advanced Drug Delivery, Pharmaceutical Sciences, R&D, Astrazeneca, Boston, 35 Gatehouse Dr., Waltham, Massachusetts, 02451, USA. stacey.marden@astrazeneca.com., Campbell JM; Analytical Development, GSK, 1250 South Collegeville Rd, Mail Stop UP1400, Upper Providence, Pennsylvania, 19426, USA. john.m.campbell@gsk.com., Adams N; Scientific and Laboratory Services-Analytical Sciences, Pfizer Inc, Kalamazoo, Michigan, USA., Coelho R; Regulatory Affairs, Eurofarma Laboratórios SA, Itapevi, São Paulo, Brazil., Foti C; Analytical Development and Operations, Gilead Sciences Inc., Foster City, California, USA., Franca JR; Brazilian Health Regulatory Agency (ANVISA), Brasilia, DF, Brazil., Hostyn S; Janssen Research & Development, LLC, a Johnson & Johnson Company, Predictive Analytics & Stability Sciences Coe, Beerse, Belgium., Huang Z; Drug Product Development, Bristol-Myers Squibb Co., New Brunswick, New Jersey, USA., Ultramari M; Spektra Soluções Científico-Regulatórias Ltda, São Paulo, Brazil., Zelesky T; Analytical Research & Development, Pfizer Inc., Groton, Connecticut, USA., Baertschi SW; Baertschi Consulting LLC, Carmel, Indiana, USA.

Publikováno v: The AAPS journal [AAPS J] 2024 Aug 22; Vol. 26 (5), pp. 96. Date of Electronic Publication: 2024 Aug 22.

Assessing the Relevance of Solution Phase Stress Testing of Solid Dosage Form Drug Products: A Cross-Industry Benchmarking Study.

Autor: Campbell JM; CMC Analytical, GlaxoSmithKline, Upper Providence, PA 19426, USA. Electronic address: john.m.campbell@gsk.com., Foti C; Analytical Core Teams, Gilead Sciences Inc., Foster City, CA, USA. Electronic address: chris.foti@gilead.com., Wang C; Analytical Core Teams, Gilead Sciences Inc., Foster City, CA, USA., Adams N; Pfizer, Scientific and Laboratory Services - Analytical Sciences, Pfizer Inc., Kalamazoo, MI 49001, USA., Allain LR; Merck & Co., Inc., Kenilworth, NJ 07033, USA., Araujo G; Global Technology & Engineering, Pfizer Inc., Itapevi, SP, Brazil., Azevedo R; Global Technology & Engineering, Pfizer Inc., Itapevi, SP, Brazil., Franca JR; Brazilian Health Regulatory Agency (ANVISA), Brasilia, DF, Brazil., Hicks SR; CMC Analytical, GlaxoSmithKline, Stevenage, Hertfordshire, UK., Hostyn S; Predictive Analytics & Stability Sciences CoE, Janssen Pharmaceutica, Johnson & Johnson, Beerse, Belgium., Jansen PJ; Eli Lilly and Company, Synthetic Molecule Design and Development., Kotoni D; Chemical & Analytical Development, Novartis Pharma AG, Basel, Switzerland., Kuemmell A; Analytical Research & Development, Novartis Pharma AG, Basel, Switzerland., Marden S; Advanced Drug Delivery, Pharmaceutical Sciences, R&D, AstraZeneca, Boston, MA, USA., Rullo G; Global Regulatory Affairs, AstraZeneca Pharmaceuticals Gaithersburg, MD, USA, 20878., Santos ACO; Global Analytical Technology, Merck S.A., Rio de Janeiro, RJ, Brazil, an affiliate of Merck KGaA, Darmstadt, Germany., Sluggett GW; Analytical Research & Development, Pfizer Inc., Eastern Point Road, Groton, CT, 06340, USA., Zelesky T; Analytical Research & Development, Pfizer Inc., Eastern Point Road, Groton, CT, 06340, USA., Baertschi SW; Baertschi Consulting LLC, Carmel, IN 46033, USA.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2022 Feb; Vol. 111 (2), pp. 298-305. Date of Electronic Publication: 2021 Jun 07.

The Degradation Chemistry of Prasugrel Hydrochloride: Part 1-Drug Substance.

Autor: Baertschi SW; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285., Maxwell-Backer L; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285., Clemens M; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285., Smitka TA; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285., Draper JR; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285., Taylor KW; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285., Kaerner A; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285., Jansen PJ; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285. Electronic address: jansen_patrick_j@lilly.com.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2019 Sep; Vol. 108 (9), pp. 2842-2857. Date of Electronic Publication: 2019 Apr 11.

Artifactual degradation of secondary amine-containing drugs during accelerated stability testing when saturated sodium nitrite solutions are used for humidity control.

Autor: Sluggett GW; Analytical Research & Development, Pfizer Inc., Eastern Point Road, Groton, CT, 06340, USA. Electronic address: gregory.w.sluggett@pfizer.com., Zelesky T; Analytical Research & Development, Pfizer Inc., Eastern Point Road, Groton, CT, 06340, USA., Hetrick EM; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, 46285, USA., Babayan Y; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, 46285, USA., Baertschi SW; Baertschi Consulting, LLC, Carmel, IN, 46033, USA.

Publikováno v: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2018 Feb 05; Vol. 149, pp. 206-213. Date of Electronic Publication: 2017 Oct 29.

Method validation and characterization of stress degradation products of azelastine hydrochloride using LC-UV/PDA and LC-Q/TOF-MS studies.

Autor: Shekhar S; University Institute of Pharmaceutical Sciences, UGC Center of Advanced Study, Panjab University, Chandigarh, India., Bali A; University Institute of Pharmaceutical Sciences, UGC Center of Advanced Study, Panjab University, Chandigarh, India.

Publikováno v: Rapid communications in mass spectrometry : RCM [Rapid Commun Mass Spectrom] 2024 Apr 15; Vol. 38 (7), pp. e9712.