Impact of API (Active Pharmaceutical Ingredient) Source Selection on Generic Drug Products
نویسندگان
چکیده
منابع مشابه
Stable isotopic composition of the active pharmaceutical ingredient (API) naproxen.
A survey of the multi-stable isotopic composition of an active pharmaceutical ingredient (API), naproxen, was performed to assess the potential of Isotope Ratio Mass Spectrometry (IRMS) to distinguish the provenance of APIs. Twenty-six lots of naproxen from six manufacturers representing four countries (Italy, India, Ireland, and the USA) were analyzed for three isotope ratios (13C/12C, 18O/16O...
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The purpose of this study was to investigate the quality of hydroxyprogesterone caproate (HPC) active pharmaceutical ingredient (API) sources that may be used by compounding pharmacies, compared to the FDA-approved source of the API; and to investigate the quality of HPC injection samples obtained from compounding pharmacies in the US, compared to the FDA-approved product (Makena(®)). Samples o...
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ژورنال
عنوان ژورنال: Pharmaceutical Regulatory Affairs: Open Access
سال: 2015
ISSN: 2167-7689
DOI: 10.4172/2167-7689.1000136