Literature DB >> 24281749

Recent trends in product development and regulatory issues on impurities in active pharmaceutical ingredient (API) and drug products. Part 1: Predicting degradation related impurities and impurity considerations for pharmaceutical dosage forms.

Karen M Alsante1, Kim Huynh-Ba, Steven W Baertschi, Robert A Reed, Margaret S Landis, Mark H Kleinman, Christopher Foti, Venkatramana M Rao, Paul Meers, Andreas Abend, Daniel W Reynolds, Biren K Joshi.   

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Year:  2013        PMID： 24281749      PMCID： PMC3909161          DOI： 10.1208/s12249-013-0047-x

Source DB:  PubMed          Journal:  AAPS PharmSciTech        ISSN： 1530-9932            Impact factor:   3.246


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  28 in total

Review 1.  Reactive impurities in excipients: profiling, identification and mitigation of drug-excipient incompatibility.

Authors:  Yongmei Wu; Jaquan Levons; Ajit S Narang; Krishnaswamy Raghavan; Venkatramana M Rao
Journal:  AAPS PharmSciTech       Date:  2011-09-27       Impact factor: 3.246

Review 2.  The role of degradant profiling in active pharmaceutical ingredients and drug products.

Authors:  Karen M Alsante; Akemi Ando; Roland Brown; Janice Ensing; Todd D Hatajik; Wei Kong; Yoshiko Tsuda
Journal:  Adv Drug Deliv Rev       Date:  2006-11-15       Impact factor: 15.470

3.  Detection and quantification of low-molecular-weight aldehydes in pharmaceutical excipients by headspace gas chromatography.

Authors:  Zhong Li; Laura K Jacobus; W Peter Wuelfing; Mary Golden; Gregory P Martin; Robert A Reed
Journal:  J Chromatogr A       Date:  2006-02-03       Impact factor: 4.759

4.  The application of the Accelerated Stability Assessment Program (ASAP) to quality by design (QbD) for drug product stability.

Authors:  Kenneth Craig Waterman
Journal:  AAPS PharmSciTech       Date:  2011-07-12       Impact factor: 3.246

5.  Evaluation of hydroperoxides in common pharmaceutical excipients.

Authors:  Walter R Wasylaschuk; Paul A Harmon; Gabriella Wagner; Amy B Harman; Allen C Templeton; Hui Xu; Robert A Reed
Journal:  J Pharm Sci       Date:  2007-01       Impact factor: 3.534

6.  An evaluation of chemical photoreactivity and the relationship to phototoxicity.

Authors:  Mark H Kleinman; Mark D Smith; Edit Kurali; Sarah Kleinpeter; Kaina Jiang; Yongxia Zhang; Sonya A Kennedy-Gabb; Anthony M Lynch; Chris D Geddes
Journal:  Regul Toxicol Pharmacol       Date:  2010-06-30       Impact factor: 3.271

7.  Establishment and intra-/inter-laboratory validation of a standard protocol of reactive oxygen species assay for chemical photosafety evaluation.

Authors:  Satomi Onoue; Kazuhiro Hosoi; Shinobu Wakuri; Yumiko Iwase; Toshinobu Yamamoto; Naoko Matsuoka; Kazuichi Nakamura; Tsuguto Toda; Hironori Takagi; Naoto Osaki; Yasuhiro Matsumoto; Satoru Kawakami; Yoshiki Seto; Masashi Kato; Shizuo Yamada; Yasuo Ohno; Hajime Kojima
Journal:  J Appl Toxicol       Date:  2012-06-13       Impact factor: 3.446

8.  The effect of surface charge on the hydrolysis kinetics of partially hydrogenated egg phosphatidylcholine and egg phosphatidylglycerol in aqueous liposome dispersions.

Authors:  M Grit; D J Crommelin
Journal:  Biochim Biophys Acta       Date:  1993-03-17

9.  Chemical hydrolysis of phospholipids.

Authors:  N J Zuidam; D J Crommelin
Journal:  J Pharm Sci       Date:  1995-09       Impact factor: 3.534

10.  Physical (in) stability of liposomes upon chemical hydrolysis: the role of lysophospholipids and fatty acids.

Authors:  N J Zuidam; H K Gouw; Y Barenholz; D J Crommelin
Journal:  Biochim Biophys Acta       Date:  1995-11-22
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