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How to determine the quality and purity of pharmaceutical intermediates?

2023-06-29 16:46:20
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The quality and purity of pharmaceutical intermediates are important indicators for evaluating their compliance with requirements. Reasonable judgment methods can ensure that the quality and purity of pharmaceutical intermediates meet the required standards. The following will introduce some commonly used methods to determine the quality and purity of pharmaceutical intermediates.

 

Firstly, the most commonly used method is to use physical properties to determine the quality and purity of pharmaceutical intermediates. The physical properties of intermediates include appearance, density, solubility, melting point, and boiling point. Generally speaking, high-quality intermediates should be colorless or white crystals with high density, high melting and boiling points, and good solubility in appropriate solvents.

 

Secondly, the evaluation of chemical properties is also a commonly used method. The chemical properties of intermediates can be determined through various experimental methods. For example, infrared spectroscopy analysis can be performed to determine whether the structure of the intermediate is correct by observing the absorption peak. In addition, techniques such as nuclear magnetic resonance spectroscopy and mass spectrometry can be used to further confirm the structure of intermediates. These analysis methods can determine whether the intermediate has high purity and correct structure.

 

Furthermore, chromatographic analysis is also one of the commonly used methods for determining the quality and purity of pharmaceutical intermediates. Chromatographic analysis can separate intermediates based on the separation effect of chromatographic columns on different substances, and calculate the content of intermediates by detecting the area and height of peaks. Chromatographic analysis can provide quantitative data for the quality and purity of intermediates, and compare them with standard standards to determine whether the intermediates meet the requirements.

 

In addition, mass spectrometry technology can also be used to evaluate the quality and purity of pharmaceutical intermediates. Mass spectrometry technology can convert intermediates into gas and analyze them using a mass spectrometer to obtain information on the mass, molecular structure, and molecular weight of the intermediates. By comparing with the standard product, it can be determined whether the quality and purity of the intermediate are qualified.

 

Finally, biological activity evaluation is also one of the important methods for determining the quality and purity of pharmaceutical intermediates. The biological activity evaluation of intermediates can be conducted through in vitro or in vivo experiments. In vitro experiments can evaluate the biological activity of intermediates at the cellular level, such as cell proliferation inhibition rate, cell apoptosis, and other indicators. In vivo experiments can evaluate the biological activity of intermediates through animal experiments, such as pharmacodynamic research and toxicological evaluation.

 

In summary, the quality and purity of pharmaceutical intermediates can be determined through various methods such as physical properties, chemical properties, chromatographic analysis, mass spectrometry, and biological activity evaluation. These methods can be combined and applied comprehensively to ensure the accuracy and reliability of the judgment results. At the same time, attention should also be paid to the control of the intermediate production process to ensure compliance with drug quality standards, in order to improve the quality and purity of pharmaceutical intermediates.


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