: Contains over 420 fully referenced excipient monographs , including 13 entirely new additions such as various amino acids and hydrated silicon dioxide.
: Updated toxicity data and non-clinical safety assessments for global regulatory compliance.
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: International synonyms and chemical abstracts service (CAS) registry numbers.
Understanding how an excipient is synthesized or extracted helps formulators anticipate potential trace impurities (such as residual solvents or heavy metals) that could interact with sensitive APIs. 4. Functional Uses
: Many of the 420+ monographs now include IR, Raman, and NIR spectra to assist in material identification.
The print version includes an improved supplier directory with web hyperlinks and a historical timeline infographic of excipients. Availability and Access
The , published in 2020 by the Pharmaceutical Press , is a comprehensive reference featuring over 420 monographs. It provides updated regulatory, physical, and safety data for excipients used in drug formulation. Core Content Structure
At the back of the book (and in the PDF's appendix), there is an index that lists excipients by function. For example, if you need a , you will find 20 options from croscarmellose sodium to sodium starch glycolate with direct page references.
: Physical properties like particle size distribution, flowability, and moisture content that affect manufacturing.
The Handbook of Pharmaceutical Excipients is not just another reference book. It is internationally recognized as the world’s most reliable and comprehensive source of information on the substances used alongside active pharmaceutical ingredients (APIs) in drug products. First published in 1986, it has evolved through nine editions, becoming an indispensable tool for anyone involved in drug development, production, or regulation.
Reviewers and pharmaceutical specialists highlight several core strengths:
This handbook is a joint publication by the and the Pharmaceutical Press . It serves as a comprehensive guide to the safety, science, and regulation of inactive drug ingredients.
Each entry is thoroughly peer-reviewed to ensure accuracy and relevance.
The handbook is not a substitute for the USP-NF or Ph. Eur. It tells you what an excipient does; the pharmacopeia tells you how to test its purity. Use both.