2.4.1 Establishment of reference substances
Fourteen new International Chemical Reference Substances1 were adopted by the Committee according to the procedure described in the thirty-second report (5). It was noted that the stock of the previously established Reference Substance 4-epitetracycline ammonium salt was depleted and that it had been replaced by 4-epitetracycline hydrochloride.
1 Amodiaquine hydrochloride, bacitracin zinc, beclometasone dipropionate, dexamethasone phosphoric acid, dexamethasone sodium phosphate, dopamine hydrochloride, framycetin sulfate. (-)-3-(4-hydroxy-3-methoxyphenyl)-2-hydrazino-2-methyIalanine, liothyronine sodium, neamine hydrochloride, probenecid, pyrantel embonate, spectinomycin hydrochloride, vincristine sulfate.
The total collection now comprises 166 International Chemical Reference Substances and 12 Melting Point Reference Substances (Annex 2).
The Committee was interested to see the preliminary information concerning the use of Reference Substances that had been gathered from the user questionnaire, and suggested that the WHO Collaborating Centre for Chemical Reference Substances should pursue these enquiries. It would be especially important to clarify the extent to which Reference Substances were used directly as working standards rather than as intended, i.e. as primary standards to calibrate local working standards. It was also suggested that this aspect of their use should be brought to the attention of those ordering Reference Substances.
The Committee expressed its appreciation to the WHO Collaborating Centre for Chemical Reference Substances for its work and to the National Corporation of Swedish Pharmacies for its continued financial support for the WHO programme on International Chemical Reference Substances.
2.4.2 Infrared reference spectra
Further to the spectra established at the Committee's previous meeting, it adopted six additional International Infrared Reference Spectra.1 Those listed in Annex 3 are now available from the WHO Collaborating Centre for Chemical Reference Substances, Stockholm, Sweden. It was noted that a number of additional infrared spectra are currently being validated. Precise instructions for the preparation of spectra are provided with each reference spectrum. Recommendations for the preparation and use of infrared spectra in pharmaceutical analysis, which will accompany the reference spectra, were approved by the Committee (Annex 4).
1 Colchicine, erythromycin stearate, glibenclamide, salbutamol, salbutamol sulfate, sulfadoxine.
The WHO Collaborating Centre for International Infrared Reference Spectra, Zurich, Switzerland, which is responsible for preparing the Reference Spectra, had proposed that spectra should in future be recorded with both dispersive and Fourier transform infrared (FTIR) spectrometers in order to take into account the current availability of FTIR spectrophotometric equipment. This proposal was endorsed by the Committee. It would be the responsibility of those ordering spectra to state the type required. To facilitate the exchange of data and their use in computer spectral searches, the Committee proposed that the FTIR spectral computer files should be stored in the format recommended by the Joint Committee on Atomic and Molecular Properties.