Chemistry Reference
In-Depth Information
The British Pharmacopoeia
The
British Pharmacopoeia
(BP) is a substantial document which
contributes to overall control of the quality of medicinal products by
providing an authoritative statement of the quality a product is expected to
achieve at any time during its period of use. The standards of the BP are
publicly available, legally enforceable and are designed to complement and
assist the UK licensing and inspection processes.
The topic itself comprises:
Volumes I and II
Monographs
of
Medicinal
Substances,
arranged
alphabetically
Volume III
Formulated Preparations, Blood, Radiopharmaceutical
and Immunological Products
Volume IV
Appendices (reagents, analytical techniques, etc), IR
spectra, Index
Volume V
BP (Vet)
Volume VI
CD-ROM version and list of British Approved Names
There is also a searchable online version of
the text available at
http://www.pharmacopoeia.org.uk/
As was stated in Chapter 6, each substance in the British
Pharmacopoeia is given a specific
monograph
, which lists the chemical
structure of the compound (if known), the definition and statement of BP
limits (quoted to one decimal place), a description of its characteristics
(colour, solubility, etc.), some tests for identification of a sample of the
material and limit tests for impurities. The monograph ends with the offi-
cial BP assay for determination of purity and the chemical structures of
known impurities which may be present as by-products of the synthesis or
decomposition products formed on storage. Formulated medicines may
have, in addition to a specific monograph, a
general monograph
, which
applies to that class of medicine (tablets, suspensions, etc.). Importantly, the
letters 'BP' after the name of the medicine imply compliance with both the
requirements of the specific monograph for the drug and the requirements
of the general monograph for the medicine. A sample monograph for
Triprolidine Hydrochloride is reproduced below.
(Ph Eur monograph 0968)
H
N
, HCl
N
Me
