Abstract：
:Medroxyprogesterone acetate (MPA) injectable products are a key commodity for reproductive health and are available in the global market from a variety of manufacturing sources. Depending on the climatic zone conditions of the destination country for product use, MPA injectables are at risk of exposure to adverse transport and storage conditions. Analytical methods are available that quantify impurity levels in MPA and MPA injectable products, but minimal information is publicly available on the source of impurity and degradation product generation or the safety risk of these compounds. Forced degradation studies were conducted on MPA and MPA injectables to gain a better understanding of potential sources of impurities and degradation products. Furthermore, QSAR analysis was conducted to assess the toxicity risk of known impurities. More impurities were generated under acidic, basic, light, and oxidative forced degradation conditions relative to thermal degradation, however thermal exposure is the most likely adverse condition to be experienced by these products. Even if impurities are present in MPA injectables, QSAR analysis found that known impurities for MPA are apparently no more of a safety risk than MPA.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Jenkins D,Harmon CL,Jia X,Kesselring A,Hatcher D,Grayson K,Ayres Jdoi
10.1016/j.jpba.2020.113352subject
Has Abstractpub_date
2020-08-05 00:00:00pages
113352eissn
0731-7085issn
1873-264Xpii
S0731-7085(19)33116-4journal_volume
187pub_type
杂志文章abstract：:The mechanism of interaction of the non-steroidal antiinflammatory drugs meloxicam and nimesulide with human and bovine serum albumin has been studied using fluorescence spectroscopy. There was only one high affinity site on serum albumin for both the drugs with association constants of the order of 10(5). Negative en...
journal_title：Journal of pharmaceutical and biomedical analysis
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journal_title：Journal of pharmaceutical and biomedical analysis
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journal_title：Journal of pharmaceutical and biomedical analysis
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journal_title：Journal of pharmaceutical and biomedical analysis
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journal_title：Journal of pharmaceutical and biomedical analysis
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journal_title：Journal of pharmaceutical and biomedical analysis
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journal_title：Journal of pharmaceutical and biomedical analysis
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journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
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journal_title：Journal of pharmaceutical and biomedical analysis
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journal_title：Journal of pharmaceutical and biomedical analysis
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journal_title：Journal of pharmaceutical and biomedical analysis
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更新日期：2018-10-25 00:00:00
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journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
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journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.08.001
更新日期：2017-10-25 00:00:00
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journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.01.016
更新日期：2008-06-09 00:00:00
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journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
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journal_title：Journal of pharmaceutical and biomedical analysis
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journal_title：Journal of pharmaceutical and biomedical analysis
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journal_title：Journal of pharmaceutical and biomedical analysis
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journal_title：Journal of pharmaceutical and biomedical analysis
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journal_title：Journal of pharmaceutical and biomedical analysis
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