Impurities Synthesis

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Impurities Synthesis

Impurity profile studies play significant roles in active pharmaceutical ingredient (API) development, which are closely related to the quality, safety and efficacy of drug products. And the impurity profile of API for drug products requires studying in the view of stringent quality standards. The recent guidelines published by International Conference on Harmonization (ICH) recommended identification and characterization of all the impurities present at a level of ~0.10% or more. Regulatory agencies give significant importance to quantifying the impurities present in the drug substance and also in the drug product. Hence impurities standards are required in pure form.

Impurities Synthesis Figure 1. The content of enantiomeric contaminants

Sources of drug impurities

Pharmaceutical impurities are generally related to specific drugs and can be divided into organic impurities and inorganic impurities. Derived from the following aspects:

  • Stems from the solvent, catalyst and so on which are commonly used in the pharmaceutical production process.
  • The raw materials, such as reaction initial complex, synthetic intermediates, by-products and so on, which are related to the formation process.
  • The products of oxidation, decomposition and hydrolysis during storage.
  • The optical isomers in the chiral compounds.
  • Multiple crystal forms of the drug.
  • There are not only alkaloids, volatile oil and organic acids, but also protein, tannin, starch, resin and other impurities in the extracts of animal and plant drugs.
  • Attenuating substances in radioactive drugs.
  • Proteins abnormally expressed in bioengineered products.
  • Heavy metals and inorganic salts.

Below is a list of Our Drug Impurity Synthesis Strategy (include but not limited to the following):

  • Production stock separation
    Enrichment and Separation of impurities by recrystallization, HPLC and SFC.
  • Chemical strong degradation of the raw drug
    Synthesis of degradation products of API by Acid-base degradation, Oxidation degradation, and Photodegradation.
  • Simulation and Optimization of process conditions for API.
    Simulation and Optimization of the process conditions for improving the impurity content in the reaction.
  • New synthesis Route of impurity.
    Synthesis of impurities in raw materials by high efficiency and new route.

Why Choose BOC Sciences?

BOC Sciences can provide various types of methods to help you synthesize impurity, whatever group or chemical constitutions you want to introduce. We are expert at designing the routine and using multiple techniques (NMR, LCMS, GCMS, and X-ray) to analyze compounds after the impurity synthesis completed. Our advantages as following:

  • A state-of-the-art synthesis and analysis laboratory.
  • Professional research team.
  • Perfect operation process.
  • Rich synthetic experience.
  • Efficient one-stop service

References

  1. Klussmann, M., Ratjen, L., Hoffmann, S., Wakchaure, V., Goddard, R., & List, B. (2010). Synthesis of TRIP and analysis of phosphate salt impurities. Synlett2010(14), 2189-2192.
  2. Bharathi, C. H., Prabahar, K. J., Prasad, C. S., Srinivasa Rao, M., Trinadhachary, G. N., Handa, V. K., ... & Naidu, A. (2008). Identification, isolation, synthesis and characterization of impurities of quetiapine fumarate. Die Pharmazie-An International Journal of Pharmaceutical Sciences63(1), 14-19.
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