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Pharmaceutical Research
Analytical Testing Center

Analytical Testing Center

Medicilon Analytical Testing Center is located in Medicilon Nanhui Park, with a total analytical laboratory area of 2800 square meter. The established GMP system has passed NMPA on-site inspections and actively promotes CNAS certification.


We follow the requirements of global pharmaceutical regulations and select nearly 200 high-end sophisticated instruments from global instrument manufacturers, have more than 120 experienced analytical scientists and the proportion of masters and PhDs exceeds 30%, and equip with prediction software ACD for facilitating analytical method development, various of testing service platform, and genotoxic impurity prediction software QSAR to complete product safety control and production quality control, to provide high-standard analysis and testing services for customers, and to facilitate the launch of new drugs and the internationalization process.


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ServicesServices
Services
  • Medicilon Analytical Testing Center can provide integrated analytical solutions and technical services, fully supporting new drug development, drug CMC application and productrelease.
    ❖ Comprehensive Technical Services
    Method development and validation, analytical testing and release, stability studies, large-scale separation, CMC filing and other services
    ❖ Extensive Project Experience
    We have extensive project experience in physical and chemical testing, chromatographic testing, drug product testing, special testing, etc.
    ❖ Analytical Services Platform
    Genotoxicity research, physical and chemical characterization research, microbial limit research, impurity preparation and structural identification, trace impurity residual solvent analysis, trace impurity elemental impurity analysis, safety assessment test, analytical method development and quality monitoring and other service platforms
List of Analytical Testing Services

Physical and Chemical Testing Items

appearancewater content
acidityresidue on ignition ROI
thermogravimetric analysis TGAdifferential scanning calorimetry DSC
infrared IRcrystal form XRPD
loss on drying LODultraviolet UV
hygroscopicity DVSparticle size distribution PSD
nuclear magnetic NMR
melting point
solubility
Potentiometric titration
specific rotationsolution color and  clarity
foreign matter detectionInsoluble particles

Chromatographic Testing Items

Ion chromatography ICGC
GC-MS/MSchiral purity HPLC
HPLCLC-MS/MS
elemental impurity ICP-MSGPC

Preparation Testing Items

osmotic pressurespecific gravity
buffer capacitysurface tension
water loss and leakagedissolution/filling capacity
viscosityfluidity
dissolutionLog P
Log DpKa
Zeta potentialdissolution behavior of artificial intestinal juice
dissolution behavior of artificial gastric juicebulk density
tap density… ….

Special Testing Items

microbial detectionendotoxin
single strain detectionresidual oxygen determination
in vivo release study (IVRT)in vitro release study (IVPT)
rheology studyparticle size distribution
cone penetrationwater activity
delivery rate and total delivered amountaerodynamic particle size distribution
droplet size distributionatomizer inspection
MEC… ….

Special Services Items

preparation and separation of impuritieschiral resolution
structural identification and structure elucidationsafety assessment (RC1, ARC, TD24)
PGI genotoxic impurity screeningstability study
(influencing factors, bottle opening, low temperature/freeze-thaw cycle, long-term, accelerated stability test)
excipient ratio/model analysisin vitro phosphate binding equilibrium test and kinetic test
in vitro bile salt binding equilibrium test and kinetic testin vitro BSA protein binding test
in vitro pepsin activity inhibition testin vitro BE method development and validation
in vitro BE statistical analysis and determination… ….
Specific Analysis Work
  • QSAR Basic Poison Screening
    The Analytical Testing Center has equipped with professional structural evaluation software Case Ultra, which includes both expert knowledge rule prediction software GT_EXPERT (1.9.0.2.17309.500) and statistical model prediction software GTI_BMUT (1.9.0.2.13760.500).  The combination of the two models can fully meet the ICH M7 requirements.
    For the research on mutagenic impurities, we are equipped with a professional and experienced impurity qualitative and quantitative research team and advanced instruments and equipment.  Research work includes:
    Screening for identified genotoxic impuritiesDevelop analytical methods for genotoxic impurities (GC-MS/MS or LC-MS/MS)Validation of genotoxic impurity analysis methods (validation includes specificity, accuracy, linearity, solution stability)Data collection of genotoxic impurities in multiple batches of samples
  • Impurity Preparation and Structural Identification Analysis
    The drug impurity preparation and structure confirmation team uses abundant preparation equipment and a variety of advanced analytical technologies (NMR, LC-MS/MS, HRMS, dual-ternary mass spectrometry, etc.) to provide clients with impurity samples of different orders of magnitude that meet R&D purity requirements, and provide support for impurity research and impurity control.  We can also provide structural confirmation analysis reports that meet CTD requirements to help clients complete product declaration and successfully obtain approval.  The impurity spectrum research process is as follows:
    Multi-batch sample testingMulti-batch sample testingPreliminary identification of possible impurities by LC-MS fragmentationProcurement or synthesis of proposed identified impuritiesDetermine known and unknown impurities in multiple batches of samplesFinalize impurity quality standards and specifications for intermediates/APIs
  • Safety Assessment Test Platform
    The safety assessment laboratory of the Analytical Testing Center is a national high-tech enterprise laboratory focusing on testing needs in the chemical industry.  We have the fine chemical reaction safety risk testing instruments and laboratory construction solutions.  We also are the professional developer of testing instruments, equipment and solutions in the chemical industry. Safety risk research and assessment work includes the following three aspects:
    Using calorimetric equipment (RC1) to conduct reaction calorimetry experiments to obtain data such as heat of reaction, ΔTad (adiabatic temperature rise), MTSR (maximum temperature that an out-of-control system may reach)Using differential scanning calorimeter (DSC) and accelerating rate calorimeter (ARC) to test the thermal stability of process-related chemical substances such as reaction raw materials, reaction completed materials, intermediate products, and distillation bottom materials to obtain the starting point data such as decomposition temperature, decomposition heat, specific heat, TD24 (the temperature corresponding to the time when the maximum reaction rate of the out-of-control system reaches 24 hours)Based on the data obtained from the above experiments and analytical tests, conduct a reaction safety risk assessment, including decomposition heat assessment, out-of-control reaction severity assessment, out-of-control reaction possibility assessment, risk matrix assessment and reaction process hazard level assessment
  • Microbiological Testing
    We have established a complete microbiology-related testing platform, and our microbiology laboratory complies with the GMP management system recognized by China and the United States.  Environmental cleanliness and other items comply with relevant regulatory requirements.  The ultra-clean workbench, biological safety cabinet, incubator and other equipment involved in the test have all passed 3Q certification and are regularly maintained and calibrated to ensure the reliability, accuracy and authenticity of the data.
    We not only provide a good microbiology research reference for project research and development, but also develop new microbiology research business, provide clients with more personalized microbiology research services, and meet the various needs of clients.  For example, we provide clients with method development, validation and testing of microorganisms and bacterial endotoxins for APIs and different types of drug products.
    For endotoxin testing, the Analytical Testing Center has established a mature process and has completed endotoxin testing, method development and validation of hundreds of domestic and foreign new drugs and generic drugs.  The project cycle is short, fast and accurate, and it is widely recognized by clients.
Dedicated Laboratory and Instrument Resources
  • EquipmentModel/SpecificationQuantity
    HPLC(DAD/CAD)Agilent/Shimadzu/Waters/Thermo76
    GCShimadzu/Agilent /PE12
    GC-MS, GC-MS/MSAgilent2
    LC-MS,LC-MS/MSShimadzu/Agilent /Thermo9
    UPLC-MS/MSAgilent1
    ICP-MSPE1
    ICThermo ICS5000+2
    KFMettler V30/SC30S3
    DSC/TGAMettler TGA2/DSC32
    DVSIntrinsic PLUS/Surface Measurement Systems1
    TOCShimadzu1
    XRPDBruker D8 Advance1
    Auto TitratorsMettler Toledo
    Thermal SafetyMettler RC1mx / THT ARC2
    PSDMalvern Mastersizer 30001
    Prep-HPLCGilson/Waters2
    Stability ChamberMemmert ICHL256/HPP1400/Freezer/Refrigerator10
  • Chromatographic -HPLC Lab.webp

    HPLC Lab

    Chromatographic - GC Lab.webp

    GC Lab

    Chromatographic -LC-MS-MS Lab.webp

    LC-MS/MS Lab

    Chromatographic-ICP-MS Lab.webp

    ICP-MS Lab

    Chromatographic-LC-MS Lab.webp

    LC-MS Lab

    Chromatographic-GC-MS Lab.webp

    GC-MS Lab

    Physical and Chemical Testing Items-physical and chemical lab.webp

    Physical and Chemical Lab

    Physical and Chemical Testing Items-Hot room.webp

    Hot Room

    Physical and Chemical Testing Items-DVS Lab.webp

    DVS Lab

    Physical and Chemical Testing Items-XRPD Lab.webp

    XRPD Lab

    Special Testing Items-safety assessment lab.webp

    Safety Assessment Lab

    Special Testing Items-Preparation room.webp

    Preparation Room

    Special Testing Items-Stability Room.webp

    Stability Room
    Microbiological Testing-Culture room and sterilization room.webp
    Microbiological Testing-Culture Room and Sterilization Room
    Microbiological Testing-Limit clean room and positive clean room.webp
    Limit Clean Room and Positive Clean Room