You only need to weigh the small sample powdered solid product (or solution) and convert the active ingredient in the compound of the elements. Get more background information with materials from isearch. Data obtained using elemental analyzer (the definition of N, F, Cl, Br, P and S) and GC / AED has shown that the proposed approach ensures the correct determination of the active ingredient in tablets without the use of standard samples of the active ingredient. This approach, as shown by our experiments, and to spare definition of the active substance in pharmaceutical substances. More info: isearch. The advantages of our approach: no need for extraction and in the presence of standard samples for each of the identified active components and to conduct him to calibration conditions for determining the elemental analyzer using universal for all identified substances, regardless of their structure, high performance test (time one definition - 3-7 min., depending on the elements) the amount of product needed for analysis, 1 mg or less, which is important for expensive pharmaceuticals and substances, the ability to quickly detect the most common counterfeit, in which the content of the active ingredient does not meet specified. Despite the merits and the possibility of using elemental analysis for the control of the active component in pharmaceuticals, in literature there are no publications devoted to the rapid and accurate determination of the active ingredient, as well as rapid and reliable confirmation of its presence in pharmaceutical preparations. The quality of a pharmaceutical (therapeutic efficacy, the presence of side effects) is determined not only by the content of active ingredient, but the number of impurities, their nature and content. It is well known that therapeutic activity of original products made by companies on the patented technology, it is often much higher than the therapeutic efficacy of generic drugs produced by other technologies.

The difference in side effects for the original drugs and generic drugs are even higher. Even at roughly the same therapeutic efficacy and bioequivalence of generic and original farmprepartov for the last observed in some cases, a significant number of side effects during their absence at the first place. We can assume that this is due to differences in the composition of impurities and their content. The usual approach to the comparison of the original pharmaceuticals and related generic drugs based on the determination of bioequivalence (rarely) and therapeutic efficacy (very rare). Comparison of profiles of impurities (sredneletuchih and non-volatile) for both products is not is because is not required. Determined only by the specified impurities such methods as high performance liquid (HPLC) and thin-layer (VETSH) chromatography, and much rarer - HPLC / MS. Gas chromatography (GC) is used rarely and only for the determination of volatile solvents specified. Missing a test method for rapidly comparing the physiological activity of original pharmaceuticals, generics, and the corresponding pharmaceutical substances. Source: Journal 'Remedium'.