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    medicine analysis
    Drug analysis includes method development and method validation, analytical testing and release, stability research, etc.:

    Method development and validation

    • Various chromatographic techniques (HPLC, UPLC, GC, and IC) and detection techniques (UV, MS, MS/MS, ELSD, FID, fluorescence, etc.) types of compounds;
    • Contents or related substances used in stability studies for raw materials and pharmaceutical preparations (tablets, capsules/liquid capsules, liquid preparations/emulsions, powder preparations, pills/coated pills, injections, topical drugs, solid dispersions, etc.) Analysis and detection methods;
    • Detection methods including dissolution (IR, ER, MR) for solvent residues, genotoxic impurities, enantiomer separation, ion chromatography, microbial testing, etc.;
    • Conduct method development experimental design, progress report, method verification plan and verification report, drug analysis method, etc.;

    analysis test

    • Determine the degradation pathway and provide application materials;
    • Perform Leachable/extractable detection;
    • Perform compound structure identification and configuration confirmation testing, etc.;
    • Analytical support for drug formulation development and cleaning verification;
    • CoA for standard material calibration or complete standardization report, etc.;
    • Structural identification of impurities or degradation products by LC/MS/MS and various nuclear magnetic resonance spectroscopy;

    Stability study

    • The stability of drug registration; the stability of trials and exploratory studies; the stability of the drug after approval;批準上市后藥物的穩定性;
    • Plan design of stability research, project management, stability sample storage and testing, data trend analysis, drug shelf life evaluation and NDA/MAA application dossier preparation, etc.;
    • Qualified stability research constant temperature and humidity box (IQ/OQ/PQ certification); stable power supply; real-time temperature and humidity monitoring (dual systems); automatic alarm system;

    According to the characteristics of the dosage form, combined with the physical and chemical properties and stability of the drug, the production conditions and equipment are considered, process research is carried out, the preparation process of laboratory samples is initially determined, and the corresponding process control indicators are established.
    We have tablets, capsules, granules; injections, oral liquids, syrups, ointments, creams, tinctures, liniments; sprays, gels and other preparation process research and quality research commonly used equipment and instruments.


    Generic drug development

    RLD selection, RLD comprehensive analysis and development of analytical methods. Screening of key excipients and comparison of key quality indicators of RLD to determine prescriptions. QbD-based production process parameters. Optimization of packaging materials and container screening. Process amplification and technology transfer. Survey