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Issue 02 - 07/2001
English
47
APPENDIX
Pharmacopoeia
In general, there has been an increase in laboratory requirements to conform with
Good Laboratory Practice techniques; this is particularly the case in Pharmaceutical
companies and in Biotechnology facilities, where the interest in finding solutions to
gene therapy opportunities is great. Typically, scientists working in pharmaceutical
and bio-pharmaceutical research, be it University or Industry, require a high
specification instrument with the ability to develop methods.
The British Pharmacopoeia (A88 Appendix II B) states that for resolution:
•
To verify the resolution of the instrument, the spectrum of a 0.02% (v/v) solution
of toluene in hexane should b recorded; the ratio of the absorbance at the
maximum (269nm) and minimum (266nm) should be at least 1.5. It can be shown
that this requires an instrument having 1.8nm bandwidth or less.
The European Pharmacopoeia (1984, v.6.19, 2
nd
Edition) states that for stray light:
•
To verify the stray light of the instrument, the absorbance of a 1.2 % w/v
solution of potassium chloride with a pathlength of 1cm should be more that
2.000 when compared with water as reference liquid.
This instrument fulfils the requirements of the Pharmacopoeia, and is delivered with
the appropriate factory final test certificate to show this. An “Instrument
Qualification and Performance Verification Logbook” is also included; this details the
various tests that have to be done to prove Pharmacopoeia compliance and enables
the results to be plotted as a function of time.
