Quantitative analysis of active pharmaceutical ingredients (APIs)
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Analysis of Potential Genotoxic Arylamine and Aminopyridine Impurities in Active Pharmaceutical Ingredients Agilent 1290 Infinity LC system and Agilent 6460A Triple Quadrupole MS system for method development and fast analysis
This Application Note illustrates the possibilities of the Agilent 1290 Infinity LC system and the Agilent 6460A Triple Quadrupole Mass Spectrometer for quantitative analysis of potential genotoxic impurities (PGIs) in active pharmaceutical ingredients (APIs). A generic approach was used to determine arylamine and aminopyridine PGIs in selected APIs. The influence of column length and mobile ph...
متن کاملAnalysis of molecular interactions in solid dosage forms; challenge to molecular pharmaceutics.
The molecular states of active pharmaceutical ingredients (APIs) in pharmaceutical dosage forms strongly affect the properties and quality of a drug. Various important fundamental physicochemical studies were reviewed from the standpoint of molecular pharmaceutics. Mechanochemical effects were evaluated in mixtures of APIs and pharmaceutical additives. Amorphization, complex formation and nanop...
متن کاملElsevier Editorial System(tm) for Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy Manuscript Draft Manuscript Number: SAA-D-11-01528 Title: Characterization of Solid Polymer Dispersions of Active Pharmaceutical Ingredients by 19F MAS NMR and Factor Analysis
Current pharmaceutical research encounters with the problem of low solubility of many 14 active ingredients (APIs). To overcome this limitation the poorly water-soluble drugs are formulated as 15 solid dispersions in matrices of hydrophilic polymers. In these new dosage formulations, besides the 16 notoriously discussed polymorphism and a bit mysterious pseudopolyamorphism, precise structural 1...
متن کاملImpurity Profiling: Theory and Practice
There is an ever increasing interest in impurities present in APIs. Now days, not only purity profile but also impurity profile has become mandatory according to various regulatory authorities. In the pharmaceutical world, an impurity is considered as any other inorganic or organic material, or residual solvents other than the drug substances, or ingredients, arise out of synthesis or unwanted ...
متن کاملSuspensions as a Valuable Alternative to Extemporaneously Compounded Capsules.
The objective of this study was to determine the variation in content of 74 different active pharmaceutical ingredients (APIs) and compare it with what is known in the literature for the content uniformity of extemporaneous prepared capsules. Active pharmaceutical ingredients quantification was performed by high-performance liquid chromatography, via a stability-indicating method. Samples for a...
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تاریخ انتشار 2015