by Clifford Nilsen

This book details the critical industrial techniques and principles needed by analytical chemists, laboratory supervisors, and managers.

Beginning with common mistakes and their impact, the text covers sample handling, basic volumetric and gravimetric principles, modern instrumental techniques, traditional wet methods, and regulatory issues such as calibration, treatment of data, documentation, development, validation, and failure investigation. The author gives full attention to regulations and the monographs of the USP.

A practical "how-to" format streamlines readers' understanding of areas such as assay, content uniformity, dissolution, preservative challenge testing, impurity profiles, and plant process support testing.

Contents

1. Introduction
2. The Stupid Things Chemists Do!
3. Fundamental Laboratory Skills
4. Shortcuts & Old Tricks Plus Calculations That Work
5. Navigating the USP
6. The Bulk Pharmaceutical World
7. The Finished Dosage Form World
8. A Sensible Plan for Design & Execution of Cleaning Validation
9. Process Validation
10. Practical Analytical Methods
11. Design & Execution of Analytical Method Validations
12. Working With a Regulatory Eye

Appendices: Acronyms/Chemical Formulas

click here to see books • videos • cd-roms of related interest