E-DRUG: WHO CD-ROM - The International Pharmacopoeia 2014
------------------------------------------------------------------------------------------------
Newly available:
CD-ROM - The International Pharmacopoeia
This new CD-ROM contains the updated Fourth Edition of The International Pharmacopoeia, 2014.
It comprises the two main volumes, together with the First, Second, Third and Fourth Supplements.
Special features.
* New monograph on capreomycin sulfate
<http://apps.who.int/phint/en/d/Jb.6.1.88/>
For the first time, the chemical composition of this fermentation product is fully defined. Suitable test methods are provided to identify the substance and to measure its purity and content. The purity requirements will greatly help manufacturers to limit the presence of impurities - and hence the toxicity - of capreomycin finished pharmaceutical products (FPP).
* Notes on guidance: dissolution testing of tablets and capsules
<http://apps.who.int/phint/en/d/Jb.10.3.1/>
Besides information on The International Pharmacopoeia policy on dissolution testing this note clarifies that although chewable tablets are intended to be chewed before being swallowed, "they may be swallowed whole and therefore performance-testing requirements for conventional-release tablets should be applied to chewable tablets."
Different market surveillance studies have revealed serious efficacy problems with chewable tablets, in particular against neglected tropical diseases. The text will support national regulatory authorities in ensuring that manufacturers justify and demonstrate the biopharmaceutical characteristics of their chewable products.
* Revision of the monograph on Artemisinin
<http://apps.who.int/phint/en/d/Jb.6.1.48/>
The monograph on Artemisinin was aligned to the previously published quality requirements for artemisinin used as a starting material. Manufacturers can now evaluate the two artemisinin qualities using the same analytical methods.
* New chapter on Reference substances and reference spectra
<http://apps.who.int/phint/en/d/Jb.10.1.1/> i
n the "Supplementary information" section
This chapter is based on experiences with the establishment of International Chemical Reference Substances (ICRS) which can also be transferred to other reference standards including secondary standards. Hands-on advice, for example, on the calculation of the assigned content following the mass balance approach, is provided.
New and revised texts
New and revised texts have been introduced for eight monographs on active pharmaceutical ingredients, 15 monographs on FPPs, one general monograph, three methods of analysis and three texts for the section on "Supplementary information".
Infrared Reference Spectra
Many monographs in The International Pharmacopoeia include an identification test using infrared spectroscopy; these tests usually allow comparison either with a spectrum obtained from ICRS or with an International Infrared Reference Spectrum (IIRS). Eight additional spectra have been newly added to the IIRS collection.
Editorial changes
The title of monographs on injections was changed. Moreover, following the publication of the 18th Edition of the WHO Model List of Essential Medicines, information on the strength of medicines was updated in several monographs. The reagent section was completely reviewed and updated.
The International Pharmacopoeia includes a collection of recommended procedures for analysis and specifications for the determination of pharmaceutical substances, excipients and dosage forms intended to serve as source material for reference or adaptation by any World Health Organization (WHO) Member State wishing to establish pharmacopoeial requirements. The pharmacopoeia, or any part of it, shall have legal status, whenever a national or regional authority expressly introduces it into legislation. The International Pharmacopoeia is based on advice and decisions from the WHO Expert Committee on Specifications for Pharmaceutical Preparations.
The support from numerous experts, national quality control laboratories, institutions and pharmacopoeias, as well as WHO Collaborating Centres, is gratefully acknowledged.
The CD-ROM can be obtained as follows:
WHO Press, 1211 Geneva 27, Switzerland
Tel +41 22 791 32 64 - Fax +41 22 791 48 57 - Email: bookorders@who.int<mailto:bookorders@who.int>
Website: http://www.who.int/bookorders
With best regards,
Sabine Kopp
Dr Sabine Kopp | Group Lead, Medicines Quality Assurance |
HIS/EMP/RHT/TSN | Technologies Standards and Norms |
Regulation of Medicines and Other Health Technologies |
Essential Medicines and Health Products |
World Health Organization |
20, Avenue Appia, CH-1211 Geneva 27 | Switzerland |
"KOPP, Sabine" <kopps@who.int>