• <progress id="ete9x"></progress>
  • <dd id="ete9x"></dd>

    <dd id="ete9x"><track id="ete9x"></track></dd><tbody id="ete9x"><noscript id="ete9x"></noscript></tbody>

    Our work includes analysis and purification including chiral separation, high-throughput purification, physical and chemical properties determination, impurity separation and identification:

    • Chiral and achiral separation;
    • Extraction, separation and structure analysis of natural products;
    •  Separation and structure analysis of raw materials and drug impurities;
    • High affinity selective mass spectrometry (ASMS) to screen small molecules;
    • Determination of physical and chemical properties (pKa, LogP / LogD, solubility and concentration);
    • Drug development analysis: including monitoring and quality control of APIs, intermediates, raw materials and finished products;

    Method development and method validation

    • API method development and verification (according to Chinese Pharmacopoeia, US Pharmacopoeia, European Pharmacopoeia, ICH, etc.)
    • Residual solvent method development and verification (in accordance with Chinese Pharmacopoeia, US Pharmacopoeia, European Pharmacopoeia, ICH, etc.)

    Routine analysis

    • NMR 1D, 2D, etc. (including H-NMR, C-NMR, P-NMR, F-NMR, HSQC, HMBC, COSY, NOESY, etc.)
    • LC-MS analysis
    • HPLC analysis (including ELSD detection)
    • Chiral purity test
    • Pre-HPLC preparation and separation
    • Routine physical and chemical tests (ROI, LOD, Cl-, SO42-, mp, HM, optical rotation, moisture determination, heavy metal residues, etc.)

    Drug Impurity Analysis

    • Use HPLC and other technologies to separate and supervise impurities in starting materials, intermediates, APIs and pharmaceutical products
    • Collect complete 1D/2D NMR, LCMS, EA, HRMS, IR, UV and other data to identify the structure of the separated impurities
    • Separation and structure identification of forced oxidative degradation products of API
    • Use quantitative NMR (QNMR) to quickly determine the content of crude materials, intermediates, API and synthetic impurities
    • Prepare application materials