(1999; 168 pages) [Spanish]
3.1 Establishment of International Chemical Reference Substances
Twenty-eight new International Chemical Reference Substances1 were adopted by the Committee according to the procedure described in the thirty-second report (8). It was reported that the depleted stock of benzil, a melting point reference substance, had been replaced with a new batch. The total collection now comprises 193 chemical reference substances and 12 melting point reference substances (Annex 1). The Committee was informed that, in accordance with the general guidelines for the establishment, maintenance and distribution of chemical reference substances (see section 3.4 and Annex 3) and the principles of good manufacturing practices (GMP), each International Chemical Reference Substance would now be accompanied by a signed certificate.
1 Amidotrizoic acid, 3-amino-2,4,6-triiodobenzoic acid, benzil, betamethasone sodium phosphate, calcium folinate, chloroquine sulfate, doxorubicin hydrochloride, erythromycin B, erythromycin C, flucloxacillin sodium, fludrocortisone acetate, gentamicin sulfate, hydrocortisone sodium succinate, levonorgestrel, loperamide hydrochloride, mebendazole, methotrexate, nifurtimox, paracetamol, paromomycin sulfate, praziquantel, prednisolone hemisuccinate, prednisolone sodium phosphate, sulfacetamide, tamoxifen citrate, tamoxifen citrate E-isomer, testosterone enantate, toluene-2-sulfonamide.
It was suggested that, to avoid unnecessary delays in making newly established chemical reference substances available, a procedure of approval by correspondence might be considered as an interim measure between meetings of the Committee.
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 to the WHO programme on International Chemical Reference Substances.