The International Pharmacopoeia (Ph. Int.) - monograph development
The work on The International Pharmacopoeia is carried out in collaboration with members of the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations and with other specialists. The process involves consultation of and input from WHO Member States and drug regulatory authorities, WHO Collaborating Centres and national drug quality control laboratories in all six WHO regions, standard-setting organizations and parties, including regional and national pharmacopoeias and with manufacturers around the world. Clearly defined steps are followed in the development of new monographs (see below).
The selection of monographs for inclusion in The International Pharmacopoeia recognizes the needs of specific disease programmes and the essential medicines nominated under these programmes; it is based primarily on those substances included in the current WHO Model Lists of Essential Medicines.
For information on adopted texts see relevant section link
General monographs
General methods
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2.3 Sulfated ash
pdf, 67kb -
3.2 Sterility test
pdf, 405kb -
3.3.1 Microbial examination of non-sterile products : microbial enumeration tests
pdf, 264kb -
3.3.2 Microbial examination of non-sterile products: test for specified microorganisms
pdf, 303kb -
3.4 Test for bacterial endotoxins (revision)
pdf, 379kb -
5.1 Uniformity of content for single-dose preparations
pdf, 71kb -
5.3 Disintegration test for tablets and capsules
pdf, 196kb -
5.6 Extractable volume for parenteral preparations (revision)
pdf, 23kb -
5.7 Tests for particulate contamination
pdf, 266kb -
S.3.1 Tablet friability
pdf, 67kb -
S.3.6 Bulk density and tapped density of powders
pdf, 287kb -
S.3.7 Microbiological quality of non-sterile products: recommended acceptance criteria for pharmaceutical preparations
pdf, 119kb