SVIBOR - Project code: 3-04-322


Strossmayerov trg 4, HR - 10000 ZAGREB
tel.: +385 1 459 44 44, fax: +385 1 459 44 69


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Project code: 3-04-322

Investigation of Materials and Methods for Pharmacopoeial Metrology

Main researcher: GRDINIĆ, VLADIMIR (14312)

Type of research: applied
Duration from: 01/01/91.

Papers on project (total): 83
Papers on project quoted in Current Contents: 11
Institution name: Farmaceutsko-biokemijski fakultet, Zagreb (6)
Department/Institute: Department of Analytics and Quality Control of Medicines
Address: A. Kovačića 1
Phone: 385 (0)41 445134
Phone: 385 (0)1 4550398

Summary: Applied investigation for the development of pharmacopoeial metrology is performed. This investigation contains an unroundaboud part of basic research activities on which a teoretical concept and an evolution of modern methodological principals in the analysis of pharmaceutical substances and pharmaceutical dosage forms as well as in preparation of chemical reference substances is constructed. Some guidelines is offered regarding approaches to the generation of the varied materials required for analytical quality control, particularly for pharmacopoeias and quality control of medicines. Major investigations in such endeavour are the goal of the undertaking and role of the final product, selection of candidate analytical procedures, their matematical-statistical verificatio by Gottschalk' standardization, then preparation, characterization and certification of materials, also making relevant software packets. The approach to chemical and physical characterization relies on the measurement philosophy, selection of analyte, their speciation, and selection of analytical methods for establishment of quality and quantitative levels. With the view to attempting to fill some of the gaps in the Croatian repertoire of reference materials and to have suitable product for laboratories' use, preparation has been completed of twelve reference materials for correction and control melting point, and azithromycin (polymorph A) for identity tests and assay. Finally, the "Dictionary of Metrology" which contains about 500 entries of scientific terms in common use in quality control of medicine, and the manual "Pharmacopoeial Nomenclature: Proposal for Croatian Linguistic Norm and Codification in Pharmacopoeia" was prepared.

Keywords: pharmacopoeia, reference materials, good measurement practices, good analytical practices, pharmaceutical analysis, software packet, performance testing, purity test, standardization, drug substances, differential scanning calorimetry, spectroscopy, melting point determination, azithromycin, chemometrics

Research goals: Goals of investigation are: 1. determination of methodology for the preparation of reference materials; 2. guidance for the evaluation of procedures in analytics and control of medicines; 3. development os software packets as a tool in pharmaceutical analysis; 4. contributions for construction and development of Croatian Pharmacopoeia; 5. preparation of relevant chemical reference substances. Results of investigation are as follows: 1. the methodology is established for the preparation of reference substances as the starting point in investigations; 2. phase solubility analysis and differential scanning calorimetry, particularly in sense of purity determination of the pharmaceutical substances were studied; 3. algorithm for evaluation of procedure in analytics and control of medicines is defined and corresponding mathematic-statistical model on the some quantitative analytical procedures are applied; 4. contributions in the field of good analytical practices, pharmacopoeia, metrology, and analytical chemistry are given, especially by certain procedures for identity and assay of analyte, for quality control of medicines, and for identification of powdered vegetable drugs on the base of microchemical procedures and microscopical search; 5. software packets for: evaluation of analytical procedure (ESKULAP), identification of powdered vegetable drugs (MIKROID), purity determination by differential scanning calorimetry (DSCOUT) and phase solubility analysis (FAZAN), ruggedness test (RUGGMET), and analysis of laboratory test results (INTFAR) were made; and 6. 13 new materials from the order of chemical reference substances needful for national metrology: azobenzene, vanillin, benzil, acetanilide, phenacetin, benzanilide, sulfanilamide, sulfaguanidine, dicyandiamide, saccharin, caffeine, phenolphthalein, and azithromycin were made.

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Last update: 10/13/95