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The different pharmacopoeias such as the British Pharmacopoeia, United State Pharmacopoeia, and Indian Pharmacopoeia are slowly incorporating limits to allowable levels of impurities present in APIs or formulations. Various methods are used to isolate and characterize impurities in pharmaceuticals, such as, capillary electrophoresis, electron paramagnetic resonance, gas—liquid chromatography, gravimetric analysis, high performance liquid chromatography, solid-phase extraction methods, liquid—liquid extraction method, Ultraviolet Spectrometry, infrared spectroscopy, supercritical fluid extraction column chromatography, mass spectrometry, Nuclear magnetic resonance NMR spectroscopy, and RAMAN spectroscopy. This reveals the need and scope of impurity profiling of drugs in pharmaceutical research. The impurities in drug products can be attributed not only to the drug substance or inert ingredients used for formulating a drug product; but they can also be brought into the drug product through the formulation process or by contact with packaging of the various impurities that can be found in drug products. In general, most of these impurities are small molecules. This is especially true in solid dosage forms where the limited mobility restricts the reactivity of larger molecules.
The United States Food and Drug Administration FDA and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation ICH be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product. This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related synthesis and formulation impurities and degradation products to meet critical requlatory requirements. It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products.
Impurity is not a much-liked word by pharmaceutical and industry people, because they are concerned about quality. Here we discuss various impurities that might be present in API formulations. As the impurity present in a drug can affect its quality and thus its efficiency, it is therefore crucial to know about impurities. The current article reveals the different terms, regulatory control, and basic techniques e. This article primarily focuses on identification and control of various impurities i. For any of the substances, quality is the prime objective.
Handbook of Isolation and Characterization of Impurities in Pharmaceuticals, Satinder Ahuja, Karen Mills Alsante (Eds.), in: Satinder Ahuja (Ser.
The control of pharmaceutical impurities is currently a critical issue to the pharmaceutical industry. The International Conference on Harmonization ICH has formulated a workable guideline regarding the control of impurities. In this review, a description of different types and origins of impurities in relation to ICH guidelines and, degradation routes, including specific examples, are presented.
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One unknown impurity Imp-II during the analysis of laboratory batches of isoproterenol hydrochloride was detected in the level ranging from 0. The unknown impurity structure was proposed as 4-[2- propanylamino ethyl]benzene-1,2-diol Imp-II using the liquid chromatography--mass spectrophotometry LC--MS analysis. Imp-II was isolated by semi-preparative liquid chromatography from the impurity-enriched reaction crude sample. The new chemical route was developed for the preparation of this impurity in required quantity with purity to use as reference standard. The most probable mechanism for the formation of Imp-II was discussed in details.
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Purchase Handbook of Isolation and Characterization of Impurities in Pharmaceuticals, Volume 5 - 1st Edition. Print Book & E-Book. ISBN
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