logo

Home

|

Products

|

9789356962026

Image of - Measuring Elemental Impurities In Pharmaceuticals A Practical Guide | Hardcover
Measuring Elemental Impurities In Pharmaceuticals A Practical Guide | Hardcover

Measuring Elemental Impurities In Pharmaceuticals A Practical Guide | Hardcover

by Thomas R.

Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities in pharmaceutical raw materials, drug products and dietary supplements. These new directives s are described in the new United States Pharmacopeia (USP) Chapters <232>, <233>, and <2232>, together with Q3D, Step 4 guidelines for elemental impurities, drafted by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), a consortium of global pharmaceutical associations, including the European Pharmacopeia (Ph.Eur.), the Japanese Pharmacopeia (JP) and the USP. This book provides a complete guide to the analytical methodology, instrumental techniques and sample preparation procedures used for measuring elemental impurities in pharmaceutical and nutraceutical materials.It offers readers the tools to better understand plasma spectrochemistry to optimize detection capability for the full suite of elemental PDE (Permitted Daily Exposure) levels in the various drug delivery categories. Other relevant information covered in the book includes: The complete guide to measuring elemental impurities in pharmaceutical and nutraceutical materials. Covers heavy metals testing in the pharmaceutical industry from an historical perspective. Gives an overview of current USP Chapters <232> <233> and <2232> and ICH Q3D Step 4 Guidelines. Explains the purpose of validation protocols used in Chapter <233>, including how J-values are calculated Describes fundamental principles and practical capabilities of ICP-MS and ICP-OES. Offers guidelines about the optimum strategy for risk assessment Provides tips on how best to prepare and present your data for regulatory inspection. An indispensable resource, the fundamental principles and practical benefits of ICP-OES and ICP-MS are covered in a reader-friendly format that a novice, who is carrying out elemental impurities testing in the pharmaceutical and nutraceutical communities, will find easy to understand.

Highlights

  • binding-icon

    9781138197961

    ISBN:

  • binding-icon

    Thomas R.

    Author:

  • binding-icon

    474

    Pages:

  • binding-icon

    215 gm

    Weight:

  • langauage-icon

    English

    Language:

  • date-icon

    2018

    Year:

  • edition-icon

    1st Edition

    Edition:

  • binding-icon

    Hardcover

    Binding:

13642

17053

Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities in pharmaceutical raw materials, drug products and dietary supplements. These new directives s are described in the new United States Pharmacopeia (USP) Chapters <232>, <233>, and <2232>, together with Q3D, Step 4 guidelines for elemental impurities, drafted by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), a consortium of global pharmaceutical associations, including the European Pharmacopeia (Ph.Eur.), the Japanese Pharmacopeia (JP) and the USP. This book provides a complete guide to the analytical methodology, instrumental techniques and sample preparation procedures used for measuring elemental impurities in pharmaceutical and nutraceutical materials.It offers readers the tools to better understand plasma spectrochemistry to optimize detection capability for the full suite of elemental PDE (Permitted Daily Exposure) levels in the various drug delivery categories. Other relevant information covered in the book includes: The complete guide to measuring elemental impurities in pharmaceutical and nutraceutical materials. Covers heavy metals testing in the pharmaceutical industry from an historical perspective. Gives an overview of current USP Chapters <232> <233> and <2232> and ICH Q3D Step 4 Guidelines. Explains the purpose of validation protocols used in Chapter <233>, including how J-values are calculated Describes fundamental principles and practical capabilities of ICP-MS and ICP-OES. Offers guidelines about the optimum strategy for risk assessment Provides tips on how best to prepare and present your data for regulatory inspection. An indispensable resource, the fundamental principles and practical benefits of ICP-OES and ICP-MS are covered in a reader-friendly format that a novice, who is carrying out elemental impurities testing in the pharmaceutical and nutraceutical communities, will find easy to understand.

Loading...

Online store of medical books

Discover a comprehensive range of medical books at our online store. From anatomy and physiology to the latest clinical guidelines, we've got you covered.

Trusted by students, educators, and healthcare professionals worldwide. Browse top publishers and expert-authored titles in every medical specialty. Enjoy fast shipping, secure payments, and easy returns. Your one-stop destination for quality medical knowledge at your fingertips.

Whether you're preparing for exams or expanding your clinical expertise, our curated collection ensures you have the right resources at hand. Dive into detailed illustrations, case studies, and up-to-date research that enhance your understanding and practical skills.

We regularly update our inventory to include the latest editions and newly released titles, helping you stay current in the ever-evolving medical field. Our advanced search and filtering tools make finding the perfect book quick and hassle-free.

Join our community of lifelong learners and medical enthusiasts. Sign up for exclusive discounts, early access to new arrivals, and personalized book recommendations tailored to your professional interests.