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Pharmacopoeia

Sep 15, 2020
Categories:  Scientific publication
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Author:  Vita Forest

While buying a particular medicine, the consumer always asks the question: is it a high-quality product? To confirm the quality, there are always two questions - is the substance contained? (determined by qualitative chemical analysis) and does the amount of this substance correspond to the declared amount? (determined by quantitative chemical analysis). The regulatory documents (pharmacopoeial monographs) that regulate the requirements for the quality of medicines (qualitative and quantitative analysis) is called pharmacopoeia. Pharmacopoeia contains monographs with information.

The pharmacopoeial monographs are divided into general and private articles.

The general pharmacopoeial monographs contain descriptions of methods for the analysis of medicines, data on the reagents and indicators used in this process.

The private pharmacopoeial monographs are the standards of medicines, which contain lists of indicators and methods of quality control of medicines and descriptions of medicines, as well as excipients and raw materials for its production. Both general and private pharmacopoeial monographs are periodically revised.

The descriptions of medicines are called monographs. 

There are also pharmacopoeial monographs for the quality control of plant extracts, plant raw materials and products from it. Sometimes monographs are included in the pharmacopoeia (for example, the Russian Pharmacopoeia). Some countries have their own separate pharmacopoeia that regulates the quality of medicinal plants (for example, the European Herbal Pharmacopoeia).

Supranational and international harmonization

The Soviet Union had a nominally supranational pharmacopoeia, the State Pharmacopoeia of the Union of Soviet Socialist Republics (USSRP), although the de facto nature of the nationality of republics within that state differed from the de jure nature. The European Union has a supranational pharmacopoeia, the European Pharmacopoeia; it has not replaced the national pharmacopoeias of EU member states but rather helps to harmonize them. The attempts have been made by international pharmaceutical and medical conferences to settle a basis on which a globally international pharmacopoeia could be prepared, but regulatory complexity and locoregional variation in conditions of pharmacy are hurdles to fully harmonizing across all countries (that is, defining thousands of details that can all be known to work successfully in all places).

It’s not surprising that this is a slow process. The World Health Organization has produced the International Pharmacopoeia (Ph.Int.), which does not replace a national pharmacopoeia but rather provides a model or template for one and also can be invoked by legislation within a country to serve as that country's regulation.

The company «VitaForest» constantly conducts the quality control of its products, starting from the preparation of medicinal plant raw materials, to the storage of finished plant extract. The control is performed in accordance with the pharmacopoeial requirements and declared methods of quality control. Thus, the company's products meet all the requirements of regulatory documentation in Russia and other countries of the world.