Foreign Pharmacopoeias Research Articles

Development of Pharmacopoeial Methods for Determining the Anticomplementary Activity of Human Immunoglobulin Preparations

The development of a pharmacopoeial method for determining the anticomplementary activity of human immunoglobulin preparations was reviewed. It was shown that the methods for determining anticomplementary activity that are used by domestic manufacturers of human immunoglobulin preparations did not comply with current international requirements, primarily because a standard sample was not used. The general pharmacopoeial monograph “Determination of anticomplementary activity of human immunoglobulin preparations for intravenous administration” that was published in the Russian Federation State Pharmacopoeia, XIIIth Edition, was formulated for the first time as a result of optimizing the conditions for determining anticomplementary activity and harmonization of the method with major foreign pharmacopoeias.

Developing approaches to dosage uniformity evaluation in the Russian State Pharmacopoeia

Dosed medicinal preparations account for a considerable part of all existing drugs. A pharmacopoeial test for dosage uniformity is required for dosed drugs. The development of methodological approaches for estimating the dosage uniformity is an essential part of standardization improvement. This test is critical for quality control of preparations, which stipulates the necessity of harmonization between requirements of the dosage uniformity test according to the Russian State Pharmacopoeia and leading foreign pharmacopoeias.

Harmonization of quality indicators of the domestic parent substance fentanyl

We present a comparative analysis of the methods for quality evaluation and standardization of the parent substance of fentanyl based on foreign pharmacopoeias and domestic regulations. Harmonization of the tests and norms is proposed for the sections identification, determination of foreign impurities, and quantification. The harmonization is carried out at the stage of monograph preparation for the revised version of existing regulations.

Systematic analysis of trimazolin hydrochloride as adrenergic vasoconstrictor

Trimazolin-hydrochloride, which is used as a pharmaceutically active component (adrenergic vasoconstrictor) for the production of decongestive preparations, was investigated in this paper by performing systematic analysis. In domestic and foreign pharmacopoeias, as well as in scientific and patent literature, there are no data on trimazolin and the methods of its investigation. Systematic analysis involves two investigation phases. A complete physicochemical characterization of the synthesized substance was done by previous investigation. In the second phase, a chemical structure of the synthesized pharmacologically active substance was confirmed to a certain degree of certainty by using the absorption spectroscopic methods (FTIR, UV-VIS, 1H-NMR). The spectroscopic methods used proved to be successful at identifying and investigating the purity of trimazolin hydrochloride. Liquid (RP-HPLC) chromatography was used for the analysis of trimazolin hydrochloride in the nasal preparation (Adrianol). The method of titrimetric analysis was developed with the aim of quantitative determination of trimazolin hydrochloride in decongestive preparations.

Harmonization of approaches to evaluation of the disintegration characteristics of tablets and capsules

A comparative analysis of requirements of the leading foreign pharmacopoeias and the existing Russian State Pharmacopoeia (RSP-XI) has been performed within the framework of the current preparation of the general pharmacopoeial article “Disintegration of Tablets and Capsules” for the future edition of RSP-XII. This analysis has revealed substantial differences in the testing procedure, the criteria of evaluation of the disintegration characteristics, and the approaches to testing various groups of medicinal preparations. Harmonized requirements and conditions of testing will be included into the corresponding article of the RSP-XII project.

Drei Berner Apotheker des 19. Jahrhunderts: Johann Samuel Friedrich Pagenstecher, Carl Abraham Fueter, Leonhard Christian Muller (review)

Reviewed by: Drei Berner Apotheker des 19. Jahrhunderts: Johann Samuel Friedrich Pagenstecher, Carl Abraham Fueter, Leonhard Christian Müller Marcel H. Bickel Claudia Zerobin. Drei Berner Apotheker des 19. Jahrhunderts: Johann Samuel Friedrich Pagenstecher, Carl Abraham Fueter, Leonhard Christian Müller. Veröffentlichungen der Schweizerischen Gesellschaft für Geschichte der Pharmazie, no. 13. Bern, Switzerland: Schweizerische Gesellschaft für Geschichte der Pharmazie / Société suisse d’histoire de la pharmacie, 1994. 360 pp. Ill. Sw. Fr. 55.00 (paperbound). The modest title “Three Bern Pharmacists of the Nineteenth Century” suggests local history. It is, and it is not. The author starts out with a background sketch of the political and economic situation in the nineteenth century, a time of important transitions. The powerful city-state of Bern, part of the then loose Swiss confederation, became the capital of the new federal state. Science proliferated, and pharmacy, a traditional art and trade, became scientific. After this introduction and a short history of pharmacy in Bern, Zerobin begins her narrative of the lives of the three pharmacists. Much as she cares for human detail and individual characterization, the three biographees have so much in common that the overall result is a large picture of the professional life of city-pharmacists. The German background of two of them reflects the fact that many liberal Germans emigrated and found a haven in the Swiss republic. The education of pharmacists was basically an apprenticeship, which was optionally complemented by short periods at an academic institution. Thus, Pagenstecher studied at Trommsdorff’s pharmaceutical institute in Erfurt, Fueter with Lavoisier and Gay-Lussac in Paris, and Müller with Liebig in Giessen. All of them were not just salespersons but used their chemical knowledge and their laboratories for scientific activities, such as analyses of drinking water, mineral waters, milk, and wine. With toxicological analyses, pharmacists even assumed forensic duties. They read papers at local scientific societies and published in journals. Being still dependent on foreign pharmacopoeias they tried to write their own. They defended the pharmacists’ realm and rights against the intrusion of physicians on the one hand and druggists, grocers, and peddlers on the other. However, they were accepted as members of the Medico-Chirurgical Society of Bern. They were also active in public health and in the service of the city government where they succeeded, for example, in creating a science museum and a botanical garden. In dealing with all these aspects and many more the author clearly transcends local history. Her work is well researched and documented in every detail. Her many sources are not only listed but often reproduced in facsimile. Unfortunately, these reproductions and the layout are somewhat poor, and an index is missing. Otherwise Zerobin’s work can be recommended as one that sheds light on many aspects of nineteenth-century medical and general civilization. Marcel H. Bickel University of Bern Copyright © 1996 The Johns Hopkins University Press

From foreign pharmacopoeias: ‘new’ antibiotics from old?

From foreign pharmacopoeias: ‘new’ antibiotics from old?