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Technical Support Centers
Analytical Testing Center Process Safety Center
Analytical Testing Center
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  • 3
    3 technical departments
  • 3
    3 technology platforms
  • 189
    R & D personnel
  • 3600 +
    research base
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The Apeloa Analytical Testing Center (AATC) is a CNAS-certified laboratory complying with cGMP. It leverages strategic resource allocation, a professional technical team, and an established quality management system to provide scientific, accurate, efficient, and safe analytical services to Apeloa's R&D, production departments, and external clients. Established in December 2021, the 3500m2 facility houses an analytical testing team of over 30 scientists. The center's platform advantages including: Compliance • CNAS certified • Audited by National Drug Administration Agency (NMPA) Efficiency • Rapid service response • Extensive project experience • Short testing turn over time
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The AATC's team comprises over 30 members, with more than 30% holding a Master's degree or higher. The quality and technical management personnel have over 10 years of experience in pharmaceutical quality standards and analytical method development. They are well-versed in domestic and international pharmaceutical quality regulations and technical standards. The team has extensive experience in areas such as unknown impurity identification, genotoxic and nitrosamine impurity studies, structural characterization, polymorphism studies, elemental impurities, and quality research for innovative and generic drugs. AATC's team have successfully completed nearly 100 projects involving genotoxic impurity studies, polymorphism studies, elemental impurities, structural characterization, and other drug quality research work, developing over 500 methods. This has accelerated the clinical research and domestic/international marketing approval of drugs.
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Quantitative and Qualitative Analysis
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Equipment
Apeloa has built a full complement of flow chemistry reactors for different scale and stage of development, including lab-scale reactors (g to 1kg scale) and Non-GMP & cGMP commercial production scale reactors (up to tons/year).
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LC-MS/MS (8 sets)
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GC-MS/MS (2 sets)
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DSC (1 sets)
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SEM x150k (1 set)
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DVS (1 set)
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XRPD (2 sets)
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ICP-MS (2 sets)
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NMR 600MHz (2 sets)
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BET (1 set)
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TGA (1 set)
No. Instrument Model
01 Nuclear Magnetic Resonance (NMR) (600MHz) AVANCE NEO 600 MHz
02 X-ray powder diffractometer, XRPD Rigaku Smart lab SE
03 Inductively Coupled Plasma Mass Spectrometer, ICP-MS Perkin Elmer NexlON 1000GE
04 LC-O-TOF Agilent 1290+6545
05 GC-O-TOF Agilent 8890GC+7250
06 LC-MSMS Shimazu LC-40A+TQ8060NX Shimazu LC-30A+TQ8060NX Agilent 12290+6470B Waters XEVO TQ-XS
07 GC-MSMS Agilent 8890+7000D Shimazu GC-2030+TQ8050NX
08 Ion chromatography, IC Thermo ICS 6000 Shimazu HIC-ESP
09 Differential scanning calorimetry, DSC Mettler DSC3+
10 TGA Mettler TGA2
11 Specific Surface Tester NovaTOuch Lx2
12 Desk Type Scanning Electronic Microscope COXEM
13 Microscopic Infrared Spectrometer iN-10
14 Dynamic Vapor Sorption (DVS) DVS Intrinsic
15 Preparative Chromatograph Shimazu LC20AP
16 Total Organic Carbon TOC-VWP
17 Elemental Analyzer EMA 502
18 ... ...
full lifecycle services
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RANGE OF FLOW CHEMISTRY REACTORS
Apeloa has built a full complement of flow chemistry reactors for every scale and stage of development. Our flow chemistry R&D reactors are designed to seamlessly scale-up to our larger pilot and commercial scale reactors, ensuring rapid and efficient technology transfers.
Lab Scale Flow Reactors (g to 1kg scale)
  • Micro reactors (Stainless steel, SiC, Hastelloy & Glass)
  • Tubular reactors (Stainless steel and Hastelloy)
  • Tangential reactors (Stainless steel and Hastelloy)
  • Photo reactors (light) with tunable UV LED radiation and glass tubes
  • Loop reactors
Our flow chemistry R&D reactors can handle G-L (gas-liquid), G-L-S (gas-liquid-separator), L-L (liquid-liquid), homo/heterogeneous reactions with stainless steel, Hastelloy (HC), Monel (nickel copper alloy), glass, and silicon-carbide (SiC) reactors. These reactors can handle flow rates ranging from 1ml/min to 1L/ minute depending on the volume of reactors and the required residence time of reaction.