Literature DB >> 24363207

Recent trends in product development and regulatory issues on impurities in active pharmaceutical ingredient (API) and drug products. Part 2: Safety considerations of impurities in pharmaceutical products and surveying the impurity landscape.

Karen M Alsante1, Kim C Huynh-Ba, Steven W Baertschi, Robert A Reed, Margaret S Landis, Scott Furness, Bernard Olsen, Mark Mowery, Karen Russo, Robert Iser, Gregory A Stephenson, Patrick Jansen.   

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Year:  2013        PMID： 24363207      PMCID： PMC3909164          DOI： 10.1208/s12249-013-0061-z

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


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  27 in total

1.  What is the true solubility advantage for amorphous pharmaceuticals?

Authors:  B C Hancock; M Parks
Journal:  Pharm Res       Date:  2000-04       Impact factor: 4.200

Review 2.  Guidelines and pharmacopoeial standards for pharmaceutical impurities: overview and critical assessment.

Authors:  David J Snodin; Sean D McCrossen
Journal:  Regul Toxicol Pharmacol       Date:  2012-04-07       Impact factor: 3.271

3.  Early prediction of pharmaceutical oxidation pathways by computational chemistry and forced degradation.

Authors:  Darren L Reid; C Jeffrey Calvitt; Mark T Zell; Kenneth G Miller; Carol A Kingsmill
Journal:  Pharm Res       Date:  2004-09       Impact factor: 4.200

Review 4.  Strategies for the investigation and control of process-related impurities in drug substances.

Authors:  Mark D Argentine; Paul K Owens; Bernard A Olsen
Journal:  Adv Drug Deliv Rev       Date:  2006-11-15       Impact factor: 15.470

5.  Identification and control of metal-chelating chromatographic artifacts in the analysis of a malonohydrazide derivative drug compound.

Authors:  Shaoping Yang; Anna Caltabiano; Lianming Wu; Jianhua Shen; Jun Chen; Alireza Kord; Leon Zhou
Journal:  J Pharm Biomed Anal       Date:  2010-04-24       Impact factor: 3.935

6.  Photodestabilization of epinephrine by sodium metabisulfite.

Authors:  J Brustugun; H H Tønnesen; W Klem; I Kjønniksen
Journal:  PDA J Pharm Sci Technol       Date:  2000 Mar-Apr

Review 7.  How does residual water affect the solid-state degradation of drugs in the amorphous state?

Authors:  E Y Shalaev; G Zografi
Journal:  J Pharm Sci       Date:  1996-11       Impact factor: 3.534

8.  Photosensitized degradation of losartan potassium in an extemporaneous suspension formulation.

Authors:  Randal A Seburg; John M Ballard; Tsang-Lin Hwang; Caitlin M Sullivan
Journal:  J Pharm Biomed Anal       Date:  2006-06-19       Impact factor: 3.935

Review 9.  The Fenton reagents.

Authors:  S Goldstein; D Meyerstein; G Czapski
Journal:  Free Radic Biol Med       Date:  1993-10       Impact factor: 7.376

10.  The role of excipients and package components in the photostability of liquid formulations.

Authors:  Robert A Reed; Paul Harmon; Denise Manas; Walter Wasylaschuk; Chris Galli; Ryan Biddell; Paul A Bergquist; William Hunke; Allen C Templeton; Dominic Ip
Journal:  PDA J Pharm Sci Technol       Date:  2003 Sep-Oct
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  7 in total

Review 1.  An overview of cephalosporin antibiotics as emerging contaminants: a serious environmental concern.

Authors:  Nilanjana Das; Jagannathan Madhavan; Adikesavan Selvi; Devlina Das
Journal:  3 Biotech       Date:  2019-05-24       Impact factor: 2.406

2.  Embryo and Developmental Toxicity of Cefazolin Sodium Impurities in Zebrafish.

Authors:  Bo Chen; Zhu-Qing Gao; Ying Liu; Yang-Min Zheng; Ying Han; Jing-Pu Zhang; Chang-Qin Hu
Journal:  Front Pharmacol       Date:  2017-06-26       Impact factor: 5.810

3.  Methodological assessment of the reduction of the content of impurities in nimodipine emulsion via the use of 21 amino acid protection.

Authors:  Yiqiao Xie; Zhiquan Zhuang; Shu Zhang; Zihua Xia; Kaiyan Fan; Jialin Ren; CuiCui Lin; Yanzhong Chen; Fan Yang
Journal:  Int J Nanomedicine       Date:  2017-04-27

4.  Informing Efforts to Develop Nitroreductase for Amine Production.

Authors:  Anne-Frances Miller; Jonathan T Park; Kyle L Ferguson; Warintra Pitsawong; Andreas S Bommarius
Journal:  Molecules       Date:  2018-01-24       Impact factor: 4.411

5.  Consequences of New Approach to Chemical Stability Tests to Active Pharmaceutical Ingredients.

Authors:  Marzena Jamrógiewicz
Journal:  Front Pharmacol       Date:  2016-02-08       Impact factor: 5.810

6.  Neurobehavioral Effects of Cephalosporins: Assessment of Locomotors Activity, Motor and Sensory Development in Zebrafish.

Authors:  Ying Han; Yangmin Zheng; Jingpu Zhang; Changqin Hu
Journal:  Front Pharmacol       Date:  2018-03-02       Impact factor: 5.810

Review 7.  Photostability of Topical Agents Applied to the Skin: A Review.

Authors:  Agata Kryczyk-Poprawa; Anna Kwiecień; Włodzimierz Opoka
Journal:  Pharmaceutics       Date:  2019-12-20       Impact factor: 6.321
  7 in total

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