Impurity Isolation and Identification

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Impurity Isolation and Identification

Isolation and identification of impurities means that impurities in the mixture are separated to increase their purity. As an important chemical method, separation and purification not only play an important role in chemical research but also play an important role in chemical production. Many important chemical research and production are based on separation and purification. The method of separation and purification has been perfected in two different directions. One is to study how to obtain high purity materials. The second is how to apply the economic separation and purification method to large-scale industrial production. The method of separation and purification is not limited to physical changes or chemical changes. Any changes in the impurities in the sample or separation of the various components in the sample may be used under the possible conditions.

Impurity Isolation and Identification

Our impurity isolation and identification services include:

  • Establishment of a mass spectrometry (MS)-ultra-high performance liquid chromatography (UPLC) method for the separation of detected impurities.
  • High resolution mass spectrometry (HRMS) was used to analyze the relative molecular weight of impurities and their molecular formulas.
  • Analysis of impurities and related compounds by pyrolysis mass spectrometry (MS/MS).
  • The consistency of MS/MS spectra of structures based on ion thermochemistry was verified by NIST MS Interpreter 2.0.
  • Separation of impurities in drugs by preparative high performance liquid chromatography.
  • The structure of impurities was analyzed by nuclear magnetic resonance (NMR).
  • According to the results of MS and NMR analysis, the molecular structure of the detected impurities was proposed.
  • Chemical synthesis of a reference material with a suggested structure.
  • The proposed structure was confirmed by comparative analysis of UPLC-MS/MS with synthetic reference materials.
  • Suggestions on the source of impurities and the ways to form them

Our Techniques for Impurity Isolation and Identification

  • Analytical Scale Chromatography - Reverse Phase, Ion Exchange and Normal Phase
  • Preparative High Performance Liquid Chromatography (HPLC)
  • Rotary Evaporation and Freeze Drying
  • Liquid Chromatography Mass Spectrometry (LC-MS)- with triple quadrupole, Time-of-Flight (ToF) and Orbitrap
  • Nuclear Magnetic Resonance Spectroscopy (NMR)
  • Fourier Transform Infra-Red Spectroscopy (FTIR)

Why Choose BOC Sciences?

Impurity separation, identification and sample purification are important aspects of pharmaceutical development, and these services are an important part of BOC Science’s support to existing compounds and new chemical/biological entities to pharmaceutical customers. Our expertise in preparative chromatography and spectroscopic techniques can support the separation and identification of impurities and the purification of active drug components (API).

References

  1. Smith, R. J., & Webb, M. L. (Eds.). (2008). Analysis of drug impurities. John Wiley & Sons.
  2. Qiu, F., & Norwood, D. L. (2007). Identification of pharmaceutical impurities. Journal of liquid chromatography & related technologies30(5-7), 877-935.
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