XRD Platform

XRD Platform is a core analytical system for solid-state drug characterization, raw material quality control and pharmaceutical R&D compliance. It enables qualitative and quantitative analysis of drug crystal forms, phase identification, microstructural characterization and inorganic impurity detection. Focusing on the key needs of pharmaceutical industry such as crystal form research, consistency evaluation and impurity control, the platform provides accurate, traceable and regulatory-compliant data support for new drug R&D, generic drug consistency evaluation, raw material and excipient quality control, and global regulatory submission.

Technology Type Core Advantages Applicable Scenarios
Powder X-ray Diffraction (PXRD) High resolution, easy operation, cost-effective, compliant with pharmacopoeia, supports quantitative analysis of crystal forms
  • Drug polymorph identification
  • Raw material crystal form consistency evaluation
  • Mixed crystal ratio quantitative analysis
  • Routine quality control
Variable-Temperature In-situ XRD Real-time monitoring, wide temperature range, in-situ detection without sample damage, captures crystal form transition dynamics
  • Solid-state drug stability research
  • Crystal form transition during temperature change
  • Desolvation process of solvates
  • Formulation process crystal form monitoring
Single Crystal X-ray Diffraction (SC-XRD) High precision, accurate crystal structure resolution, determines absolute configuration and molecular packing
  • New drug crystal form research
  • Co-crystal/salt structure characterization
  • Crystal form mechanism exploration
  • New drug patent declaration
Small Angle X-ray Scattering (SAXS) Suitable for nanomaterial characterization, non-destructive testing, high sensitivity for microstructure analysis
  • Nanopharmaceutical characterization
  • Liposome/microsphere microstructure analysis
  • Drug carrier performance evaluation

XRD Platform

PharmaAnalytica has built a standardized XRD Platform, equipped with a full range of high-performance analytical instruments. The platform covers from routine powder X-ray diffraction analysis to advanced single crystal structure resolution and in-situ variable-temperature crystal form monitoring, supporting stable, traceable and regulatory-ready testing throughout the entire lifecycle of raw materials, excipients, formulations and new drug products. It is committed to providing high-precision, comprehensive and efficient analytical solutions for pharmaceutical solid-state research and quality control.

Powder X-ray Diffractometer DX-2700BH

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A multi-functional high-resolution powder X-ray diffractometer for pharmaceutical solid-state analysis. Adopted θ-θ geometric optical design and metal-ceramic X-ray tube, it supports analysis of powder, bulk, thin-film and trace samples. With high-precision angle measurement (±0.02°) and advanced data processing software, it enables drug polymorph identification, mixed crystal quantification, raw material consistency evaluation and crystal structure refinement. Compliant with USP/EP Pharmacopoeia, it provides reliable diffraction data for generic drug evaluation and new drug crystal form patent applications.

TDM-20 Benchtop X-ray Diffractometer with In-situ High-Temperature Stage

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This is a compact benchtop X-ray diffractometer equipped with a dedicated in-situ high-temperature stage, achieving accurate temperature control from room temperature up to 1200°C. It enables real-time dynamic monitoring of pharmaceutical crystal form transformation, solvent loss behavior and thermal phase stability under simulated stress conditions. Widely applied in solid drug polymorph screening, stability investigation and formulation process compatibility assessment, it provides reliable diffraction data for pharmaceutical R&D and quality control.

TD-5000 Single-Crystal X-ray Diffractometer

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A high-end single crystal X-ray diffractometer designed for new drug R&D and crystal structure analysis. It achieves accurate resolution of single crystal structures, determination of absolute configurations, analysis of molecular packing and unit cell parameters, and precise characterization of co-crystals, salts and solvates. It provides core data support for new drug crystal form research, mechanism exploration and patent declaration.

Small Angle X-ray Scattering System SAXSFocus 3.0

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A high-performance SAXS system designed for pharmaceutical nanomaterial and biopolymer characterization. It provides atomic-to-nanoscale structural information, featuring a high-flux X-ray source, precision collimating mirrors, and an automatic beam-stop switching function. Widely applied in pharmaceutical research: nanoparticle size/distribution and internal structure analysis; liposome, LNP, and polymeric micelle microstructure characterization; protein/antibody solution conformation and aggregation assessment; in-situ monitoring of drug carrier self-assembly and stability.

Core XRD Analysis Services

Drug Crystal Form Research & Characterization

  • Qualitative identification of drug polymorphs;
  • Quantitative analysis of mixed crystal ratios;
  • Determination of crystal form purity;
  • Characterization of co-crystals, salts, solvates and hydrates;
  • Analysis of crystal form stability under storage conditions

Raw Material & Excipient Quality Control

  • Phase identification of raw materials and excipients;
  • Consistency evaluation of raw material crystal forms;
  • Detection of inorganic impurities,
  • Residual catalysts and heavy metals;
  • Screening of excipient crystal forms and purity

Formulation Process & Stability Evaluation

  • Monitoring of crystal form changes during formulation processing (granulation, tableting, encapsulation);
  • Evaluation of crystal form stability under stress conditions (high temperature, high humidity, light);
  • Verification of crystal form consistency before and after formulation

Nanopharmaceutical & Drug Carrier Characterization

  • Microstructural analysis of nanopharmaceuticals, liposomes, microspheres and mesoporous drug carriers
  • Determination of nanoparticle size and size distribution
  • Evaluation of drug carrier self-assembly and stability
  • Characterization of protein/antibody solution conformation and aggregation state
  • Analysis of the interaction between nanodrugs and carriers, providing core data support for nanodrug formulation development
  • Delivery system optimization and quality consistency control

As a core solid-state analysis module of PharmaAnalytica, the XRD Platform integrates full-range high-performance XRD testing instruments and standardized pharmaceutical-grade analysis workflows. It covers crystal form identification, polymorph quantitative analysis, in-situ thermal stability monitoring, nanomaterial microstructure characterization and inorganic impurity screening in one stop. Backed by professional technical capabilities and strict regulatory compliance standards, PharmaAnalytica delivers accurate, traceable and globally recognized testing data, providing strong support for pharmaceutical raw material quality control, formulation stability evaluation, generic drug consistency evaluation and new drug R&D registration worldwide.

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