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THE IMPORTANCE OF QUALITY CONTROL AND REGULATORY COMPLIANCE OF ACTIVE PHARMACEUTICAL INGREDIENTS: RECENT STUDY

  • Unique Paper ID: 161996
  • Volume: 10
  • Issue: 7
  • PageNo: 188-199
  • Abstract:
  • This brief review presents the international approaches to assessment of the content of geotaxis impurities (residual solvents and various inorganic and organic impurities) in pharmaceuticals. Nowadays, it has become necessary to provide not only purity profile but also impurity profile of a particular pharmaceutical product because of national and international regulations. These aspects along with significance of the quality, efficacy and safety of pharmaceuticals, including the source of impurities, kinds of impurities, control of impurities and regulatory aspects are discussed. The supply of essential medicines of good quality has been identified as one of the prerequisites for the delivery of health care system of any country as poor quality medicines can harm or even kill consumers. The presence of unwanted chemicals in a particular medicine, even in extremely small quantities, may influence its efficacy and safety. Unlike in other industries, a medicine is a dynamic product whose color, consistency, weight, and even chemical identity can change between manufacture and ultimate consumption. Hence, quality of pharmaceuticals has been a concern of the people of the whole world, and is now receiving critical attention from regulatory authorities .Impurities in pharmaceutical products are of great concern not only due to the inherent toxicity of certain contaminants, but also due to the adverse effect that contaminants may have on drug stability and shelf-life. In pharmaceutical and drug products, impurities are the unwanted chemicals (organic, inorganic and residual solvents) that remain with the active pharmaceutical ingredients (APIs), or develop/added during formulation, or upon aging. Organic impurities are the most common impurities found in every API which get incorporated normally during the multi-step synthesis process despite proper care. For achieving great deals with efficacy and safety parameters of pharmaceutical product control the in process quality consideration with ingredients and maintain good regulatory documents are matter most.
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Cite This Article

  • ISSN: 2349-6002
  • Volume: 10
  • Issue: 7
  • PageNo: 188-199

THE IMPORTANCE OF QUALITY CONTROL AND REGULATORY COMPLIANCE OF ACTIVE PHARMACEUTICAL INGREDIENTS: RECENT STUDY

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