Particle Analysis
Particle characteristics—size, distribution, morphology, surface area, and concentration—are critical quality attributes of Active Pharmaceutical Ingredients (APIs) and excipients, directly impacting drug solubility, bioavailability, stability, flowability, and formulation performance. As a leading pharmaceutical CRO, PharmaAnalytica offers a comprehensive, technology-driven Particle Analysis service portfolio for APIs and excipients, integrating cutting-edge analytical techniques to characterize particulate matter across micro- and nano-scale ranges. Our state-of-the-art platforms cover full particle property analysis, delivering precise, regulatory-compliant data aligned with ICH, USP, EP, and NMPA guidelines, and supporting every stage from API development and excipient qualification to formulation optimization and commercial QC.
Centered on laser-based detection, microscopic imaging, particle counting, and surface area analysis technologies, our services address the diverse particle characterization needs of pharmaceutical raw materials—from measuring nanoscale particle size distribution to observing microscale morphological details, and from quantifying particle concentration to analyzing specific surface area. Each technology is tailored to target distinct particle properties, ensuring full-dimensional, accurate characterization of APIs and excipients for optimal drug product development.
Specialized Particle Analysis Services
Laser Diffraction (LD)
A gold-standard for macro-to-micro particle size distribution analysis (0.01 μm–3500 μm), LD uses laser light scattering to rapidly measure particle size in dry or wet dispersions. Ideal for bulk APIs and excipients (e.g., powders, granules), it delivers high-throughput, repeatable results for quality control and formulation development, complying with USP <429> and EP 2.9.31.
Dynamic Light Scattering (DLS)
The premier technique for nanoscale particle size analysis (0.001 μm–10 μm) and polydispersity index (PDI) measurement. DLS enables non-destructive, rapid characterization of colloidal APIs, nanosized excipients, and dispersed particulate systems, providing critical data for nanopharmaceutical raw material qualification and stability testing (USP <429>).
Static Light Scattering (SLS)
Specialized for molecular weight and radius of gyration analysis of macromolecular APIs (e.g., polymers, peptides) and colloidal particles. SLS measures absolute molecular weight without calibration standards, and characterizes particle shape and aggregation state—essential for evaluating the structural integrity of biopolymer excipients and high-molecular-weight APIs.
Nanoparticle Tracking Analysis (NTA)
Enables quantitative analysis of nanoscale particles (0.001 μm–1 μm) including size distribution and absolute concentration. NTA combines light scattering with single-particle tracking, delivering high-resolution data for low-concentration nanoparticle APIs/excipients (e.g., lipid nanoparticles, nanosuspensions) and detecting rare submicron particulate contaminants.
Coulter Counter
A reference method for absolute particle size counting and size distribution analysis (0.01 μm–1000 μm) based on electrical zone sensing. Coulter Counter provides precise, non-optical particle concentration and size data for non-spherical APIs/excipients (e.g., crystalline powders, microcarriers), and is ideal for detecting and quantifying large particulate impurities in raw materials (USP <788>/<789>).
Atomic Force Microscopy (AFM)
Offers nanoscale morphological and topographical characterization (atomic to micro scale) of API and excipient particles. AFM enables high-resolution imaging of particle surface structure, shape, and roughness without sample labeling, and quantifies nanoscale particle height/diameter—critical for characterizing nanocrystalline APIs and novel excipient particle surfaces.
Transmission Electron Microscopy (TEM)
Delivers ultra-high-resolution morphological analysis (0.1 nm–μm scale) of micro/nanoparticles. TEM reveals internal particle structure (e.g., crystallinity, porosity) and external morphology of APIs/excipients (e.g., nanoparticles, microcrystals), and is the gold standard for characterizing nanoscale particulate raw materials and identifying trace nanoparticle contaminants.
Scanning Electron Microscopy (SEM)
Provides high-resolution 3D morphological imaging (1 nm–mm scale) of API and excipient particles. SEM clearly visualizes particle shape, surface texture, and agglomeration state of bulk powders, granules, and microscale particulates, supporting the optimization of API/excipient flowability and formulation process compatibility (USP <786>).
Flow Imaging Microscopy (FIM)
Enables rapid, automated characterization of individual particles (0.5 μm–100 μm) including size, shape, count, and morphology. FIM analyzes hundreds of particles per second in liquid dispersion, ideal for quantifying particulate matter in liquid APIs/excipients and screening raw material particulate impurities (USP <788>/<789>/<1788>).
Brunauer-Emmett-Teller (BET)
The definitive method for specific surface area (SSA) and pore structure analysis of porous APIs and excipients (e.g., microspheres, adsorbent excipients, porous powders). BET uses gas adsorption to measure SSA, pore volume, and pore size distribution—key parameters impacting API dissolution rate, excipient adsorption capacity, and formulation drug loading efficiency (USP <846>).
Why Choose PharmaAnalytica?
Full Technology Coverage
10 specialized analytical platforms cover all particle characterization needs—size, distribution, morphology, concentration, surface area, and structure—for APIs and excipients across micro/nano scales.
Regulatory Compliance
All methods are validated to ICH Q2(R1), USP, EP, and NMPA standards, with GLP-compliant data and reports supporting drug registration and commercial QC.
High Precision & Versatility
Adapt to diverse sample types (powders, dispersions, colloids, porous materials) and deliver ultra-sensitive, repeatable results for early R&D screening to commercial batch testing.
Expert Technical Support
Our team of analytical scientists provides customized testing protocols, in-depth data interpretation, and actionable recommendations for API/excipient optimization and formulation development.
PharmaAnalytica's Particle Analysis services turn particulate property data into actionable insights, ensuring your APIs and excipients meet stringent quality standards and drive optimal formulation performance—from raw material qualification to commercial drug product success.
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