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Pharmaceutical Analysis for Small Molecules

Behnam Davani

4.9/5 (23574 ratings)

Description:This book provides an introduction to pharmaceutical analysis for small molecules (non biologics) using commonly used techniques for drug characterization and performance tests. Determination of impurities in drugs is a unique challenge because these compounds are present at small or trace levels. Therefore, different types of impurities and common techniques for their separation and analysis are covered in a dedicated chapter. Other related topics such as setting meaningful specifications, analytical method validation, verification and method transfer are covered. A chapter is devoted to instrument/equipment qualification because generation of reliable data and analytical results depends on appropriate performance verification and calibration of such instruments.The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. Therefore, a chapter on regulatory agencies (e.g. FDA) and drug approval process is included. The approved specifications by regulatory bodies are private. However, these specifications are developed and become available as public standards (monographs) once the generic companies bring their equivalent products to market. The U.S. Pharmacopeia (USP) and other major Pharmacopeias (EP, JP) are organizations/agencies that establish such standards. Consequently, a chapter on this topic is to highlight the responsibilities and different but complementary roles that each of these compendial and regulatory organizations plays on safety, efficacy, purity, strength and overall quality of the pharmaceutical products. Due to global nature of pharmaceutical industry, topics on both regulatory (ICH) and Compendial harmonization are also highlighted.We have made it easy for you to find a PDF Ebooks without any digging. And by having access to our ebooks online or by storing it on your computer, you have convenient answers with Pharmaceutical Analysis for Small Molecules. To get started finding Pharmaceutical Analysis for Small Molecules, you are right to find our website which has a comprehensive collection of manuals listed.
Our library is the biggest of these that have literally hundreds of thousands of different products represented.

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Format: PDF, EPUB & Kindle Edition

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ISBN: 1119425018

Description: This book provides an introduction to pharmaceutical analysis for small molecules (non biologics) using commonly used techniques for drug characterization and performance tests. Determination of impurities in drugs is a unique challenge because these compounds are present at small or trace levels. Therefore, different types of impurities and common techniques for their separation and analysis are covered in a dedicated chapter. Other related topics such as setting meaningful specifications, analytical method validation, verification and method transfer are covered. A chapter is devoted to instrument/equipment qualification because generation of reliable data and analytical results depends on appropriate performance verification and calibration of such instruments.The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. Therefore, a chapter on regulatory agencies (e.g. FDA) and drug approval process is included. The approved specifications by regulatory bodies are private. However, these specifications are developed and become available as public standards (monographs) once the generic companies bring their equivalent products to market. The U.S. Pharmacopeia (USP) and other major Pharmacopeias (EP, JP) are organizations/agencies that establish such standards. Consequently, a chapter on this topic is to highlight the responsibilities and different but complementary roles that each of these compendial and regulatory organizations plays on safety, efficacy, purity, strength and overall quality of the pharmaceutical products. Due to global nature of pharmaceutical industry, topics on both regulatory (ICH) and Compendial harmonization are also highlighted.We have made it easy for you to find a PDF Ebooks without any digging. And by having access to our ebooks online or by storing it on your computer, you have convenient answers with Pharmaceutical Analysis for Small Molecules. To get started finding Pharmaceutical Analysis for Small Molecules, you are right to find our website which has a comprehensive collection of manuals listed.
Our library is the biggest of these that have literally hundreds of thousands of different products represented.

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Pharmaceutical Analysis for Small Molecules

Pharmaceutical Analysis for Small Molecules

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