Enki Biopharmaceuticals(Shanghai) Limited.

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    お問い合わせ

    本社所在地: 上海市松江区涞亭南路125号B幢(2号楼) 708室

    Tel: +86-21-57680326  受付電話番号: +86-21-57680965

    〒: 201615

品質開発

Enki has an independent quality standard research laboratory and is equipped with advanced analytical instruments. The quality standards research team is composed of R & D personnel and professionals with rich project development experience to ensure strong support for API and pharmaceutical preparation analysis and quality research to meet customer needs.

The quality standards research services we provide include, but are not limited to:


Chemical and preparation development support.

Development and verification of analytical methods (including but not limited to high performance liquid chromatography, gas phase method, gas phase headspace injection method, etc.);

Development of on-line control and content analysis methods;

Testing of raw materials;

Impurity distribution spectrum;

Separation and characterization of impurities;

The degradation products were qualitatively determined.

Compatibility test of raw materials;

Study on influencing factors and forced degradation;


Release testing of APIs and preparations.

Analysis of related substances and contents.

Solvent residue, moisture, heavy metals, burning residue, drying weight loss, standardization of work products, formulation of COA;

Study on acceleration and long-term stability;

Structure identification of impurity and degradation products of perylene.


Instruments for the study of quality standards:

The analytical laboratory is equipped with liquid chromatography-mass spectrometry, Agilent high performance liquid chromatography with diode array detector, ultraviolet detector, evaporative scattered light detector and differential refractive detector, Shimadzu high performance liquid chromatography, headspace injection and automatic direct injector, gas chromatography with hydrogen flame ion detector and thermal conductivity detector, polarimeter, melting point meter, Mettler Toledo high precision electronic balance, ultraviolet analyzer, Automatic potentiometric titrator, Karl Fischer moisture meter and other advanced instruments and equipment can be used for chromatographic analysis and physicochemical detection needed for drug research and development.