Technical Highlights of Impurity Identification of APIs

As a key quality attribute of pharmaceuticals, the study of impurities is an important systematic project. Impurity spectroscopy analysis is of guiding significance in guiding the development and optimization of pharmaceutical preparation processes. This paper compares the general principles, research ideas and practical work on impurity analysis of chemically synthesized APIs.

Regulatory requirements

CTD format filing information requires drug development companies must have the following analysis of impurity analysis studies.

(1) list the list of possible impurities in the product and analyze the source of impurities.

(2) the known impurities to give the chemical structure and provide structural corroboration study information.

(3) impurity situation analysis: impurity name, impurity structure, impurity source, impurity control limit, is not into the quality standard.

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Classification and response strategy

Organic impurity analysis is the study of the actual impurities and potential impurities in the product. Potential sources of organic impurities are process impurities and degradation products. Research methods include structural characterization, stability tests, forced degradation tests.

Inorganic impurities include catalysts, ligands and reagents; metal impurities; inorganic salts; and other substances.

Residual solvent analysis needs to list the use of organic solvents in the process: solvent name, source, solvent type, control limits, is not included in the quality standards. Residual solvents are generally detected by gas chromatography.

Chiral impurities are rarely encountered in general drug development, but are more common in chiral drugs. The study of chiral impurities is a difficult point in the study of impurities.

Impurity identification

According to the synthesis process, the impurities that may exist in the product are studied. If the impurity control can be directly purchased, it can be purchased and analyzed by mass spectrometry and hydrogen spectrometry to determine the chemical structure. But in practice, because the developed drug is relatively new and cutting-edge, there is no impurity control available in the market and cannot be purchased, so it is necessary for the R&D unit to synthesize and purify the impurity control by itself, conduct mass spectrometry and hydrogen spectrometry, and determine the chemical structure.

The determination of limits

The analysis of the impurities of the substances concerned is mainly the content and quantity of each impurity in the sample, as well as the source of each impurity. The impurity study of the substances concerned should be conducted throughout the quality study, and the basic information such as structure and toxicity should be determined for the unknown impurities with impurity content over 0.1%; both known impurities and newly added impurities should be controlled separately to determine the changes of impurities.

Conclusion

Impurity research is a very important element in the process of drug development. The State Council and the State Food and Drug Administration attach great importance to the quality of drugs, and new policies and regulations are emerging, so companies should follow the national drug policies and regulations, and carefully study the guidelines for drug development. Companies should also explore the technical points in drug analysis and establish scientific impurity research ideas and steps.

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