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    LKtime Biotech (Changchun)

    R&D Center Drug Substance (DS) production Drug Product (DP) production Quality Analysis and Control Customized CDMO Service
    Quality Analysis and Control

    Quality Analysis and Control

    The Quality Analysis and Control Center houses a 3900 m² quality control laboratory, capable of performing diverse sample testing services, including:

    Material testing

    Testing can be conducted in compliance with National Standards (GB) and Pharmacopoeial Standards (e.g., ChP, USP, EP).

    Purified Water, water for injection (WFI), and pure steam testing

    Full-range testing can be performed according to USP, ChP and EP standards.

    Microbial Strain Identification and Characterization

    • Staining and morphological analysis
    • Biochemical Profiling
    • Species identification for over 500 strains, including: gram-negative bacteria, gram-positive bacteria, fungi
    • Contaminant Mapping: customized database development for environmental and water system microbial contaminants.

    Product Testing Portfolio

    Product Testing

    Sterility Testing

    Sterility testing services are provided in compliance with pharmacopoeial requirements for pharmaceuticals, biological products, medical devices, raw materials, excipients, and other categories. By utilizing controlled manual environments, we ensure samples remain uncontaminated throughout the testing process, adhering to international standards such as GMP and FDA.
    Main Equipment

    • HPLC

    • Sterile Isolator

    • GC

    • CE System

    • Biochemical Testing
    Laboratory

    • Physicochemical Laboratory

    If you have any service needs, please feel free to leave a message.

    Content Us

    • Tel:
      131 2081 8528
    • E-mail:
      CDMO@LKTIME.CN
    • Addr.:
      2 Floor, Building 58, 260 Maoyuan Road,
      Fengxian District, Shanghai
    Copyright ©2025 LKTime All Rights Reserved Powered By VTHINK
    Shanghai ICP 2024082380号-1
    If you have any service needs, please feel free to leave a message. We will respond asap.

    Submit

    Tel: 131 2081 8528

    E-mail:CDMO@LKTIME.CN

    Addr.:2 Floor, Building 58, 260 Maoyuan Road,
    Fengxian District, Shanghai

    Copyright ©2025 LKTime All Rights Reserved Powered by VTHINK