Pharmaceutical Impurity Analysis Service

Creative Proteomics provides a pharmaceutical impurity analysis platform to assist customers to analyze the substances that have no therapeutic effect or affect the stability and efficacy of drug, or even harmful to human health. The pharmaceutical impurity analysis service of Creative Proteomics helps customers control drug purity, ensure drug quality, ensure the safety and effectiveness of medication, providing the basis for drug quality management during production and distribution.

According to the criteria/specifications of ICH and customer requirements, Creative Proteomics can develop technical guidelines to meet customer requirements, including requirements for impurities testing in new compounds, impurities testing in different preparations, and limit of residual solvents. Creative Proteomics has developed a rapid testing platform suitable for drug manufacturing enterprises and government organizations, which can be used for the pharmaceutical impurity analysis and issue the analysis report in accordance with the quality assurance/quality control plans and regulations of each country/region and your special requirements.

Detectable Products

We can provide you with the following types of pharmaceutical impurity, including but not limited to:

Organic impuritiesOrganic impurities can be introduced in the production or storage of a drug or preparation. Organic impurities may be identified or unspecified, volatile or non-volatile, including initiators, by-products, intermediates, degradation products, reagents, ligands and catalysts. The chemical structure of such impurities is generally similar to that of the active ingredient. Creative Proteomics can analyze these related substances.
Inorganic impuritiesInorganic impurities may be derived from the production process, such as used instruments, raw materials (such as arsenic and lead), drying reagents and filter aids, reaction reagents, ligands, catalysts, heavy metals, other residual metals, inorganic salts, activated carbon. Inorganic impurities are generally known and determined. Since many inorganic impurities directly affect the stability of drugs and can reflect the production process itself, the service of inorganic impurities analysis of Creative Proteomics is of great significance for the evaluation of the status of drug production process.
Residual solventsResidual solvents are organic or inorganic liquids used in the production process, generally known to be toxic.

Technology Platform and Available Services for Pharmaceutical Impurity Analysis

  • Chromatographic technology platform
  • The chromatographic technology platform of Creative Proteomics can effectively separate and detect impurities from drugs by taking advantage of the difference in chromatographic properties between drugs and impurities. Chromatographic technology platform is widely used for the analysis of impurities in drugs.

    • Thin layer chromatography (TLC). TLC method has been used in many national pharmacopoeia for the analysis of impurities in drugs. It has the advantages of simple equipment, simple operation, fast separation speed, high sensitivity and resolution, and can be used at the same time to view the spot which can obtain more information about impurities.
    • High Performance Liquid Chromatography (HPLC). HPLC has high separation efficiency, strong specificity and sensitive detection, which can accurately determine the peak area of each component. This service is increasingly used in the analysis of impurities.
    • Gas chromatography (GC). GC can be used for the analysis of volatile special impurities. ICH and pharmacopoeia of many countries require the use of GC for the analysis of residual solvents.
  • Thermal analysis platform
  • Thermal analysis platform has been widely used in the purity analysis of drugs. This service can be used for drug moisture detection, crystal water analysis, and impurity detection in drugs.

    • Thermogravimetric analysis (TGA)
    • Differential thermal analysis (DTA)

At Creative Proteomics, our professional analysts can provide you with improved quality services to support your business. Our professional analysis platform can guarantee consistently accurate and detailed delivery. If the substance or item you want to test is not in the above content, please contact us. Our professionals will customize exclusive solutions for you. Creative Proteomics looks forward to cooperating with you.

Online Inquiry

With a continuing focus on quality, we are proud of satisfying the needs of our clients both at home and abroad covering more than 50 countries and districts.

  • USA
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