Стандартные образцы производства ЕАЭС. Перспективные подходы к решению задач заказчика.
22 August 2024
News
Modern approaches to the use of standard samples (primarily primary) for various tasks of enterprises of the Russian Federation can be divided into two groups: traditional (using CRMs of European (EP), American (USP) and other generally recognized pharmacopoeias) and alternative (created by manufacturing enterprises, companies of the Russian Federation and EAEU countries).
In this article we will pay attention to the alternative approach to the primary pharmaceutical standards, both for the main substances and for impurities.
The alternative approach is based on the development, qualitative analysis, certification and production of standard samples as analogs of traditionally used in the world standards, or as absolutely new standards (for example, for new or rare substances). To solve these tasks in a complex the manufacturer needs appropriate competencies of personnel, equipment, accredited laboratory and production. The list of equipment used in such a laboratory for research of standard samples is quite large. The methods of HPLC, IR, UV, as well as NMR, mass spectrometry and, in some cases, elemental analysis are widely used.
One of the most promising directions of development of production of reference materials is the direction based on individual work of the manufacturer for the request or task of the customer. In this case it is possible to pay attention to all peculiarities of application of a standard sample, documentary, commercial and technical support of delivery.
The Center is equipped with an advanced laboratory for quality control and standardization of active pharmaceutical substances and impurity compounds. In the course of work, special attention is paid to control at all stages of production of standardized samples (SS). Starting with a detailed study and evaluation of the quality of materials and working with raw material suppliers, the company prefers manufacturers with many years of experience in the industry, who are suppliers to global industry leaders. Highly qualified employees, based on years of experience in the pharmaceutical industry, perform rigorous quality control of raw materials for all CO and impurity characterization criteria, including NMR spectroscopy, mass spectroscopy and X-ray analysis. All products are subjected to multiple quality control at various stages of production as well as post-production during stability studies of standard samples.
Authors: Lilit Safaryan, commercial director of Reflabfarm LLC, Pavel Mynkin, development director of Reatorg LLC.
Read more in the next issue of the information and analytical journal “CHEMICAL EXPERT”.
In this article we will pay attention to the alternative approach to the primary pharmaceutical standards, both for the main substances and for impurities.
The alternative approach is based on the development, qualitative analysis, certification and production of standard samples as analogs of traditionally used in the world standards, or as absolutely new standards (for example, for new or rare substances). To solve these tasks in a complex the manufacturer needs appropriate competencies of personnel, equipment, accredited laboratory and production. The list of equipment used in such a laboratory for research of standard samples is quite large. The methods of HPLC, IR, UV, as well as NMR, mass spectrometry and, in some cases, elemental analysis are widely used.
One of the most promising directions of development of production of reference materials is the direction based on individual work of the manufacturer for the request or task of the customer. In this case it is possible to pay attention to all peculiarities of application of a standard sample, documentary, commercial and technical support of delivery.
One of the partners implementing tasks of varying degrees of complexity in the EAEU market is our partner company Reflabfarm, the first manufacturer of reference materials (RM) in the Republic of Armenia, as well as a modern center of pharmaceutical innovation, specializing in the development and production of primary pharmaceutical reference materials (RM).
The Center is equipped with an advanced laboratory for quality control and standardization of active pharmaceutical substances and impurity compounds. In the course of work, special attention is paid to control at all stages of production of standardized samples (SS). Starting with a detailed study and evaluation of the quality of materials and working with raw material suppliers, the company prefers manufacturers with many years of experience in the industry, who are suppliers to global industry leaders. Highly qualified employees, based on years of experience in the pharmaceutical industry, perform rigorous quality control of raw materials for all CO and impurity characterization criteria, including NMR spectroscopy, mass spectroscopy and X-ray analysis. All products are subjected to multiple quality control at various stages of production as well as post-production during stability studies of standard samples.
Authors: Lilit Safaryan, commercial director of Reflabfarm LLC, Pavel Mynkin, development director of Reatorg LLC.
Read more in the next issue of the information and analytical journal “CHEMICAL EXPERT”.
