Abstract
A serious threat to the health of the population is falsified medicines. In a number of cases, they are identified in the process of incoming quality control for compliance with the requirements of regulatory documents for indicators “Description”, “Packaging”, “Marking”. However, in order to identify sophisticated counterfeits, only a visual assessment of the drug is not enough. Purpose screening evaluation of potentially counterfeited or poor-quality drugs using the IR spectrometry along the total spectrum. Materials and methods. The objects of research were available in freely available commercially available tablets produced by domestic and foreign manufacturers “Paracetamol Extratab”, “Solpadein fast”, “Citrapac”, “Citramon P”, “Ascofen-P”, corresponding to the requirements of the current regulatory documents. The studies were carried out on a Fourier-Spectrophotometer infrared “FSM 1201”. Results and discussion. On the example of the tablets “Citramon P”, “Ascophen-P”, “Citrapac”, “Paracetamol Extratab”, “Solpadein Fast” the possibility of using the total IR spectra as a primary screening index of authenticity is shown. It was established that the total IR spectra of medicines of similar composition reflect the similarity of serial samples of the products of one manufacturer and the difference in serial samples of products of different manufacturers.
Highlights
Falsified medicines is a serious threat to the health of the population [1, 2, 3]. They are identified in the process of incoming quality control for compliance with the requirements of normative documents on indicators “Description”, “Packaging”, “Marking”
The methods of identification of pharmaceutical substances in medicines by IR spectrometry described in the normative and scientific literature are based on the preliminary isolation of the active substance by possible means [4,5,6,7,8]
Purpose of the study was to study the possibility of an express primary screening evaluation of potentially falsified or poor-quality drugs using the IR spectrometry along the total spectrum [9, 10]
Summary
Falsified medicines is a serious threat to the health of the population [1, 2, 3] In some cases, they are identified in the process of incoming quality control for compliance with the requirements of normative documents on indicators “Description”, “Packaging”, “Marking”. To develop screening assessment methods various physicochemical methods characterized by high sensitivity are used. One of these methods is an IR spectrometry method. По нашему мнению суммарный спектр лекарственного препарата, обусловленный поглощением не только субстанций, но и вспомогательных веществ, наполнителей, корригентов, стабилизаторов и их соотношением, может служить «визитной карточкой» лекарственного средства соответствующего производителя, а также с определенной достоверностью выявлять фальсификацию за счет некоторых индивидуальных особенностей ИК-спектров лекарственных препаратов разных производителей. Purpose of the study was to study the possibility of an express primary screening evaluation of potentially falsified or poor-quality drugs using the IR spectrometry along the total spectrum [9, 10]
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