Drug Impurity profiling an emerging task to Pharmaceutical Industries now days - A Review
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چکیده
منابع مشابه
An Overview on Scientific Approaches for Impurity Profiling In New Pharmaceutical Substances and Products- A Review Article
In the pharmaceutical world, an impurity is considered as any other organic material, besides the drug substance, or ingredients, arise out of synthesis or unwanted chemicals that remains with API’s. Impurity profiling is the process of acquiring and evaluating data that establishes biological safety of an individual impurity; thus, revealing its need and scope in pharmaceutical research. The c...
متن کاملA Review on Impurity Profile in Pharmaceutical Substances
Impurity is defined as any substance coexisting with the original drug, such as starting material or intermediates or that is formed, due to any side reactions. Impurity can be of three types: Impurities closely related to the product and coming from the chemical or from the biosynthetic route itself, Impurities formed due to spontaneous decomposition of the drug during the storage or on exposu...
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Many works have appeared in various scientifically reputable journals and publications worldwide that seem to have made potential or satisfactory contribution to our knowledge on the functions and utilization of gelatin--an important source of animal protein. Irrespective of these worldwide publications, room still exists for more work to be done to fully understand the utilization, chemical, b...
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The petitioner requests that the Commissioner of the Food and Drug Administration declare that the drug product Divalproex Sodium Extended-Release Tablets, 1000 mg, is suitable for submissiol as an ANDA. The reference-listed drug product upon which this petition is based is Depakote ER (Divalproex Sodium) Extended-Release Tablets, 500 mg manufactured by Abbott Laboratories. The approval of whic...
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Nigella sativa has attracted healers in ancient civilizations and researchers in recent times. Traditionally, it has been used in different forms to treat many diseases including asthma, hypertension, diabetes, inflammation, cough, bronchitis, headache, eczema, fever, dizziness and influenza. Experimentally, it has been demonstrated that N. sativa extracts and the main constituent of their vola...
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ژورنال
عنوان ژورنال: American Journal of PharmTech Research
سال: 2019
ISSN: 2249-3387
DOI: 10.46624/ajptr.2019.v9.i2.010