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Quality Control of Chemicals

#0429-2


New Approaches to the Quality Control and Toxicological Safety Assessments of Chemical Products and Materials

Tech Area / Field

  • INS-MEA/Measuring Instruments/Instrumentation

Status
8 Project completed

Registration date
18.01.1998

Completion date
09.07.2002

Senior Project Manager
Tyurin I A

Leading Institute
Research Institute of Chemical Agents for Plant Protection, Russia, Moscow

Supporting institutes

  • Moscow State University / Department of Chemistry, Russia, Moscow

Collaborators

  • Dow Chemical Company, USA, MI, Midland

Project summary

Objective

The aim of the Project is to develop a new methodology of the quality control and toxicological safety assessment of chemical and pharmaceutical products (including highly purified ones) by determination of qualitative and quantitative composition of organic impurities, which are present in traces (up to 108 wt %) , and evaluation of their toxicological safety.

Technical Approach

To solve the Project tasks, advanced methods, which have been developed earlier by the authors, involving atmospheric pressure photoionization mass-spectrometry (APPhl/MS), chromato-mass-spectrometry with APPhI, chromatography coupled to chromatodistillation have to be used. GG/MS with electron impact (El) and chemical ionization (CI) will be used too.

Following are proposed to be developed: (1) an atmospheric pressure photoionization source and its combination with an ion trap and chromato-mass-spectrometer; (2) methods for recording APPhI mass-spectra (for different chemical compounds), which consist of only molecular and quasimolecular ions, and for determining the number of mixture components without their preliminary separation; (3) APPhl/MS method in a combination with chromatodistillation, capillary gas chromatography (GC), and high-performance liquid chromatography (HPLC); (4) methods for the identification and quantitative determination of trace impurities basing on the combined use of chromatodistillation, capillary GC, HPLC, APPhl/MS, and GC/MS (El); (5) methods for the determination of molecular weights of mixture components and their chemical structure using mass-spectrometry with ionization at a wide pressure range in an ion source and mass-spectro-mass-spectrometry (APPhI/MS/MS); (6) methods for determination of impurities chemical structure using the above-mentioned combination of analytical methods; (7) methods for non-experimental toxicological assessment of both inpidual compounds and mixtures of them.

Anticipated Results

Implementation of the Project would make it possible to design and develop instruments, to design a system of interrelated methods for determination of qualitative and quantitative composition of organic impurities in various substances and materials. This system will form the basis of a complex methodology for the quality control and toxicological safety assessment of chemical products. Unlike the present state, it will be provided the reliable determination of (i) the true number of components being present in a mixture (products), including those impurities, which аre not detectable by conventionally used methods, and (ii) molecular weights and chemical structures of components at concentrations up to 10-7 - 10-8 %. Basing on the safety assessment of mixture components, a procedure for the 3 toxicological safety estimation of chemical products will be developed.

Application of the proposed methodology will provide the improved quality control of chemical products; therefore, its quality can be upgraded, but its toxicity can be lowered due to decreasing the number and concentrations of hazardous impurities. Moreover, this Project is related with problems of the environmental pollution control especially in the case, when the composition of unknown (unspecified) compounds is necessary to be determined.

Scientific and Commercial Significance

Using these results in the Russian Federation and other countries would allow to increase reliability and accuracy of the control of the quality of chemical products and materials and the assessment of extent of their toxicological safety. The results to be obtained during Project execution will have commercial significance, since the developed methodology of the quality certification and safety assessment will be more far more reliable than the existing ones.

Roles of Foreign Collaborators

Following are potential roles of foreign Collaborators:

(i) application of the developed methodology for tasks of the environmental pollution control;

(ii) comparative studies on the quality and toxicological safety of chemical products;

(iii) design and development of instruments (including joint patenting);

(iv) marketing of the developed method (i.e. search for potential customers interested in the reliable quality and toxicological safety of products).


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