Analytical Testing Center

Services

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  Bacterial Endotoxin Test
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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

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, ΔT_ad (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

• Equipment	Model/Specification	Quantity
  HPLC（DAD/CAD）	Agilent/Shimadzu/Waters/Thermo	76
  GC	Shimadzu/Agilent /PE	12
  GC-MS, GC-MS/MS	Agilent	2
  LC-MS，LC-MS/MS	Shimadzu/Agilent /Thermo	9
  UPLC-MS/MS	Agilent	1
  ICP-MS	PE	1
  IC	Thermo ICS5000+	2
  KF	Mettler V30/SC30S	3
  DSC/TGA	Mettler TGA2/DSC3	2
  DVS	Intrinsic PLUS/Surface Measurement Systems	1
  TOC	Shimadzu	1
  XRPD	Bruker D8 Advance	1
  Auto Titrators	Mettler Toledo
  Thermal Safety	Mettler RC1mx / THT ARC	2
  PSD	Malvern Mastersizer 3000	1
  Prep-HPLC	Gilson/Waters	2
  Stability Chamber	Memmert ICHL256/HPP1400/Freezer/Refrigerator	10

• Chromatographic Detection EquipmentChromatographic Detection EquipmnentSpecial Services Laboratory EquipmentMicrobiology Laboratory Equipment

  

  HPLC Lab

  

  GC Lab

  

  LC-MS/MS Lab

  

  ICP-MS Lab

  

  LC-MS Lab

  

  GC-MS Lab

  

  Physical and Chemical Lab

  

  Hot Room

  

  DVS Lab

  

  XRPD Lab

  

  Safety Assessment Lab

  

  Preparation Room

  

  Stability Room

  

  Microbiological Testing-Culture Room and Sterilization Room

  

  Limit Clean Room and Positive Clean Room