Small Molecule Chemical Drug Testing Services
Since 2014, MedChemExpress (MCE) Analytical Service Platform has built a complete analytical technology system focusing on key aspects of small molecule drug development. It provides services such as instrument testing, compound structure identification, related substances and impurity research (including genotoxic impurities), method development and validation, and drug stability studies. With a rigorous quality management system, a comprehensive suite of accredited analytical instruments, a highly experienced testing team, and robust internal management protocols, we have built a solid foundation for service quality.
The analytical service platform not only provides various testing and analysis services related to small molecule drugs, but also offers reference standards, isotope-labeled compounds, and customized products needed for the testing process. This simultaneous provision of "testing services + products" reduces the costs of multiple intermediaries, providing clients with a one-stop solution from solution design to testing implementation and product support.
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Independent Laboratories
12000+
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Technical Teams
300+Master's and PhD
holders ≥23% -
Precision Instruments
400+
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Systematic Operations
GRLP/ GMP/ CNAS
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Serving Clients
13000+
1.Instrument Testing Services
2.Impurity Structural Identification Service
3.Analysis Method Development and Validation Services
1.Instrument Testing Services
Leveraging over 400 precision analytical instruments, advanced data analysis capabilities, and a comprehensive library of established methodologies, our analytical services platform provides integrated, end-to-end support throughout the entire drug development lifecycle. Each year, it processes over 500,000 tests, with core projects delivered within 24 hours, delivering rapid turnaround that fully supports customers’ R&D timelines.
Our Services
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NMR Test
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One-dimensional nuclear magnetic resonance (hydrogen spectrum, carbon spectrum, phosphorus spectrum, fluorine spectrum, boron spectrum, etc.)
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Two-dimensional nuclear magnetic resonance (COSY/HSQC/HMBC/NOESY, etc.)
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Quantitative NMR
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Chromatography Testing
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Liquid chromatography HPLC/ UPLC (DAD、CAD、ELSD、RI、etc.)
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Gas chromatography GC (FID、ECD)
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Ion chromatography (IC)
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Ultra-high performance liquid chromatography (UPCC)
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Mass Spectrometry Testing
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Liquid chromatography-mass spectrometry LCMS/UPLCMS (ESI、APCI)
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Two-dimensional liquid chromatography-mass spectrometry (2D-LCMS)
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Triple quadrupole liquid chromatography-mass spectrometry (LCMSMS)
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High-resolution mass spectrometry (QE)
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Quadrupole-time-of-flight mass spectrometry (Q-TOF)
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Gas chromatography-mass spectrometry (GCMS)
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Triple quadrupole gas chromatography-mass spectrometry (GCMSMS)
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Inductively coupled plasma mass spectrometry (ICP-MS)
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Crystallographic Studies
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Single crystal X-ray diffractometer (SXRD)
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X-ray powder diffractometer (XRPD)
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Differential scanning calorimeter (DSC)
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Thermogravimetric analyser (TGA)
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Determination of particle size and particle size distribution (PSD)
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Polarised light microscope (PLM)
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Specific surface area and pore size analysis (BET)
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Physical and Chemical Testing
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Moisture content testing (KF or CKF)
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Loss on drying (LOD)
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Residue on ignition (ROI)
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Potentiometric titration
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Melting point (MP)
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ultraviolet (UV)
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Optical rotation（OR）
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Infrared (IR)
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Rheometer
Main Instruments and Equipment
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High-Performance Liquid Chromatograph -
Gas Chromatograph -
Liquid Chromatography-Mass Spectrometry System -
Nuclear Magnetic Resonance Spectrometer -
Inductively Coupled Plasma Mass Spectrometer -
High-Resolution Mass Spectrometer
Service Case Study
01 ICP-MS Validation and Testing
Our metal impurity testing service has completed over 600 projects to date with detection sensitivity reaches the nanogram level. In addition, we offer an organic sample preparation module to overcome long sample digestion and testing time. This setup enables us to deliver fast and efficient testing services for our customers.
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Advanced technology
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Top-tier instruments, such as Thermo Fisher iCAP PQ and Agilent 7850 ICP-MS, offer exceptionally low detection limits and outstanding interference resistance, allowing reliable performance even in complex sample matrix;
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Advanced sample preparation techniques minimize contamination and sample loss to enhance detection efficiency;
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Substantial practical experience built through the successful execution of more than 100 elemental impurity research project services
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High-efficiency cost reduction
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Tailored elemental impurity analysis solutions based on drug characteristics and client requirements;
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End-to-end support from consultation and design, to execution and report, accelerating drug development and registration timelines;
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Significant cost reduction: Scaled testing and resource sharing reduce equipment purchase and maintenance costs, achieving more than 40% savings in service expenditure.
Linear Diagram of Ten Elements
Parameters such as elemental impurity content and detection sensitivity:
| Class | Metals | Sensitivity (ng/mL) |
|---|---|---|
| Class 1 | Cd | 0.12 |
| Pb | 0.3 | |
| As | 0.9 | |
| Hg | 0.9 | |
| Class 2A | Zr | 0.3 |
| V | 0.6 | |
| Ni | 2 | |
| Class 2B | Ag | 1 |
| Au | 1 | |
| Ir | 1 | |
| Re | 1 | |
| Pd | 1 | |
| Pt | 1 | |
| / | 1 | |
| Ru | 1 | |
| Se | 1 | |
| Tl | 2 | |
| Class 3 | Ba | 1 |
| Cr | 1.5 | |
| Cu | 1 | |
| Li | 1 | |
| Mo | 1 | |
| Sb | 1 | |
| Sn | 1 | |
| Others | Al | 6 |
| Fe | 0.5 | |
| B | 1 | |
| Ca | 100 | |
| K | 100 | |
| Mg | 100 | |
| Mn | 1 | |
| Na | 50 | |
| Zn | 10 |
02 Solid-state Analysis and Detection
The platform is equipped with high-end precision instruments including Bruker D8 ADVANCE X-ray powder diffractometers and single-crystal diffractometers. With a comprehensive screening system and advanced technical capabilities, we can accurately and efficiently identify optimal solid states. To date, we have successfully supported multiple companies in crystal-form and salt-form screening, helping overcome key challenges in new drug development and accelerating the regulatory submissions. Through multi-platform integration, we provide crystallization process development and optimization for active pharmaceutical ingredient (API) manufacturing, delivering critical technical support to enhance drug quality and reduce costs for multiple pharmaceuticals.
Typical XRPD pattern
2.Impurity Structural Identification Service
Our analytical service platform employs multiple techniques to confirm the structure of compound, efficiently interpreting spectra to deliver comprehensive analysis reports. To date, we have confirmed the structures of over 300 compounds.
Service Process
- Conduct qualitative studies on pharmaceutical process or impurities degradation using spectroscopic analysis, followed by isolation or chemical synthesis of impurities
- Perform NMR, HRMS, IR, elemental analysis, UV and other testing on impurities
- Deduce impurity structures using collected data combined with process information
- Deliver impurity structural-identification reports
- Perform quantification (qNMR or TGA, purity, etc.)
- Issue impurity COAs
Case Example
By analyzing the correlated signals between hydrogen atoms at carbon positions 1, 2, and 4 (H1, H2, and H4) in the NOESY spectrum, H4 and H1 were found to be on different planes. Combined with the synthetic-route information, the structure was inferred to be Compound 2.
Compound 1
Compound 2
NOESY Spectrum
3.Analysis Method Development and Validation Service
We provide comprehensive analytical method-development and validation services across all stages, from starting materials, intermediates, and API R&D production, to regulatory submissions.
Service Scope
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Analytical method development and validation for related substances/content, including forced degradation
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Method development, qualification, or validation for impurity residue content
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Method development, qualification, or validation for elemental impurity residue
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Method development, qualification, or validation for KF and CKF moisture analysis
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Method development, qualification, or validation for particle size distribution (PSD)
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Method development, qualification, or validation for ion content and residues
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Method development, qualification, or validation for drug chirality
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Method development, qualification, or validation for genotoxic impurities
Our Advantages
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Comprehensive Resources
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Full CSP coverage: Over 200 chiral columns including polysaccharide cyclodextrins, Pirkle, macrocyclic antibiotics, etc., supporting plug-and-play.
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Multi-dimensional instrument integration: SFC/UPCC/HPLC: CAD/ELSD (for compounds lacking UV absorption), MS (structural confirmation), Prep-SFC (preparative purification). GC: FID/MS/MS (trace analysis).
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Knowledge based Support: Experience with over 2000 chiral compounds, integrated chiral compound database, enables rapid method matching and reduces trial-and-error.
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High-efficiency Cost-reduction Mechanism
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High-throughput screening: Multiple 6-column switching HPLC and UPCC systems allow screening of over 100 chiral methods within one week.
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Seamless scale-up: SFC/UPCC integrated with preparative chromatography enables direct scaling-up to kilogram-level production.
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Modular expansion: Progression from analytical scale (UPCC) → semi-preparative (SFC) → production scale (Prep-SFC), maximizing cost utilization.
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Cost reduction: Scalable testing and resource sharing reduce R&D service costs by >40%.
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Quality and Compliance
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Validated performance: Zero-defect performance in FDA audits; repeatedly validated by client and third-party scrutiny.
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Data integrity: Automated backup of raw data and audit trails, compliant with 21 CFR Part 11 electronic data regulations.
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GLP/GMP services: Strict SOPs ensuring full traceability from sample receipt to report.
Service Case Example
Method Development for Multi-Chiral Centre Compounds
A third-generation ALK inhibitor exhibits a complex structure with a relatively large molecular weight and multiple chiral centers. The presence of flexible chains, aromatic rings, and polar groups within the molecule leads to extremely similar physicochemical characteristics (such as polarity, hydrophobicity, and hydrogen-bonding capacity) among isomers, resulting in minimal conformation differences between them. Baseline separation, precise quantification, and stability monitoring of chiral isomers present significant analytical challenges.
The analytical service platform rapidly identified preliminary separation strategies based on the compound's structural characteristics, pinpointing the separation approach. This led to the development of a chiral separation method exhibiting high resolution (Rs > 2.0, achieving baseline separation), high sensitivity (0.1%), and high robustness (delivering consistent reproducibility).
Our Service Offers
Service Consultation
Analytical testing services require evaluation before determining the appropriate plan and pricing. For further information on service pricing or technical details, please email [email protected] or contact MCE’s sales representatives directly.