Organic Impurity Test

Drug impurities may have an impact on the quality, safety and efficacy of drugs. Impurity analysis refers to the study of the distribution of known and unknown impurities present in a drug, and the analysis of the source and destination of impurities in a drug, through the study of impurities, the safety of a drug can be comprehensively evaluated. For the drug development stage, it is necessary to identify and characterize impurities in the process of art development and further confirm the source of impurities. Based on the analysis results, the developers can evaluate the safety of the drug and its consistency with the original drug, and further optimize the process according to the source of impurities to reduce or eliminate the generation of impurities. The analysis of organic impurities uses appropriate analytical procedures for identification (structural characterization), reporting and quantification, and the process of obtaining and evaluating data on the biosafety of the impurities (identification).

About Organic Impurities

Organic impurities are mainly generated during the production and storage of active pharmaceutical ingredients (APIs), but may also arise from materials used in the synthesis of active pharmaceutical ingredients, by-products and synthesis intermediates, and ligands used in the purification of active pharmaceutical ingredients. The causes of organic impurities are manifold and include nucleation, hydrolysis, oxidation, dehydration, cyclization, and photolysis. The detection of these various types of trace organic impurities is challenging and requires complete detection, separation, quantification and structural characterization techniques for drug discovery and development needs.

Our Services

CD Formulation offers a range of services for the detection, separation, structural characterization, and quantification of organic impurities. The detection methods for organic impurities include chemical, spectroscopic, and chromatographic methods, with different detection methods used depending on the drug structure and degradation products. We can screen suitable analytical techniques for our clients to separate and detect impurities of different structures in drugs to achieve effective control of impurities. Our pharmacy and chemistry researchers combine efficient and rapid separation techniques with sensitive, stable, accurate and applicable assays to separate and detect all types of common organic impurities.

The following are the specific tests we offer to our customers.

• Separation of organic impurities
• Qualitative testing of organic impurities
• Quantitative analysis of organic impurities
• Structural identification of cross-linked impurities

In addition to the above services, we can provide you with complete data reports, including raw data, data analysis and product solutions from our professionals.

Organic Impurity Analysis Instruments

• Rapid analysis for impurity separation and quantification by liquid chromatography/ultraviolet detection (HPLC/UV).
• Difficult separation of organic compounds or when supercritical chromatography is difficult to use for the separation of chiral compounds, using consideration capillary electrophoresis (CE) and supercritical chromatography (SFC).
• Structural analysis of compounds, liquid chromatography/mass spectrometry.
• Structural identification of organic impurities, Fourier infrared spectroscopy (FT-IR) and nuclear magnetic resonance (NMR).

If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.