Electron Microscope Platform
Electron Microscopy (EM) is a high-resolution imaging cornerstone in pharmaceutical R&D and quality control, enabling direct visualization and structural characterization from micrometer down to sub-nanometer scale. Combining SEM, SEM-EDS, TEM, Cryo-TEM and supporting systems, it reveals morphology, particle size, crystal habit, internal structure, elemental composition and aggregation state invisible to conventional methods. It is indispensable for solid formulation development, biologic characterization, impurity analysis and regulatory compliance. The core techniques and applications are compared below:
| Technology Type | Core Advantages | Applicable Scenarios |
| SEM | High surface resolution, large depth of field, minimal sample preparation |
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| SEM-EDS | Simultaneous imaging + elemental mapping |
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| TEM | Ultra-high internal resolution |
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| Cryo-TEM | Native state preservation, near‑atomic resolution |
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Electron Microscope Platform
PharmaAnalytica has built a high-resolution, compliant, automated electron microscope platform dedicated to pharmaceutical micro- and nano-characterization, equipped with high-performance analytical instruments to support stable, traceable and regulatory-ready testing throughout the drug lifecycle.
KYKY-EM8200
KYKY-EM8200 is a high-end field-emission scanning electron microscope featuring a Schottky thermal field-emission electron gun, advanced low-aberration electron optics, and a retarding sample stage. It delivers outstanding resolution: 0.8 nm @ 15 kV and 1.5 nm @ 1 kV, enabling high-quality low-voltage imaging of non-conductive pharmaceutical samples without metal coating. With a wide magnification range up to 3,000,000× and high stability, it is ideal for API crystal analysis, particle characterization, tablet microstructure, and foreign particulate inspection in pharmaceuticals.
Combines ultra-high-resolution SEM imaging with real-time energy-dispersive X-ray spectroscopy for simultaneous morphological and elemental analysis. It identifies foreign particulates, locates elemental impurities, analyzes API-excipient distribution and supports contaminant source tracing, fully meeting pharmacopoeial requirements for visible and sub-visible particles.
TH-F120 Field-Emission Transmission Electron Microscope
TH-F120 is a high-performance 120 kV field-emission transmission electron microscope with information resolution down to 0.14 nm. It provides ultra-high resolution for internal structural analysis of liposomes, nanoparticles, nanocrystals, microcapsules and protein assemblies, supporting design and optimization of targeted delivery systems and biologic characterization.
Totem 300S Cryo-TEM
Totem 300S is a 300 kV cryo-transmission electron microscope, delivering a resolution of 1.4 Å. It preserves samples in a native hydrated state for near-atomic imaging, and is widely used for protein conformation analysis, antibody structure characterization, virus-like particle (VLP) morphology, vaccine structure research and aggregation behavior evaluation. It provides critical structural evidence for biopharmaceutical development, consistency evaluation and regulatory submission.
Covered Drug Categories for EM Analysis
Supported by our mature and stable integrated EM platform, PharmaAnalytica provides customized, full-process analytical services covering a full spectrum of small-molecule drugs, innovative drugs, generic drugs, natural products and pharmaceutical preparations.
- Small-molecule APIs and finished pharmaceutical products
- Innovative small-molecule drugs and generic drugs
- Oral solid preparations, injections and topical formulations
- Natural products
- Biologics: proteins, antibodies, vaccines, VLPs, fusion proteins
- Nanomedicines: liposomes, nanoparticles, microspheres, nanocrystals
- Inhalation formulations, lyophilized products and ophthalmic preparations
- Pharmaceutical excipients, packaging materials and composite systems
Core EM Applications in Pharmaceutical Testing
Impurity, Contaminant & Foreign Particulate Analysis
- Visual and sub-visible particle morphological identification
- Elemental analysis and source tracing of foreign matter
- Glass delamination, flake detection and packaging compatibility
- Filtrate analysis for injectable safety evaluation
Biologics & Advanced Therapy Characterization
- Protein conformation, aggregation and fragmentation
- Antibody, enzyme and complex assembly structure
- Vaccine particle morphology, VLPs and viral vector integrity
- Post-translational modification and stability-related structural changes
API & Raw Material Characterization
- Morphology, crystal habit and particle size distribution analysis
- Polymorphism and pseudo-polymorphism distinction
- Batch-to-batch consistency and process-related structural variation
- Quantitative particle statistics for quality risk assessment
Formulation Development & Process Optimization
- Microstructure of tablets, granules and pellets
- API-excipient mixing uniformity and distribution
- Integrity and porosity of sustained‑release matrices
- Lyophilized cake structure, collapse and homogeneity
- Nanocarrier morphology, size distribution and encapsulation state
PharmaAnalytica's Electron Microscope Platform provides ultra-high-resolution structural and elemental analysis covering small molecules, nanomedicines and biologics across the entire drug lifecycle. The platform delivers precise insights into morphology, particle size, internal structure, elemental composition and aggregation behavior. Backed by compliant workflows and professional data interpretation, we support formulation optimization, quality control, impurity control and regulatory submission, helping clients accelerate R&D and ensure safe, stable and high-quality pharmaceutical products.
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