Solid-state characterization

Particle size and shape are critical material attributes for all solid dosage forms and liquid suspensions, determining crucial parameters such as bioavailability and processability. The measurement of particle size, shape, and size distribution is therefore essential throughout the drug development and manufacturing process.

Mastersizer 3000+ range

Particle sizing is critical at multiple stages of pharmaceutical development and production, and for years, the Mastersizer range has been the trusted choice for industry professionals.

The Mastersizer 3000+ is designed to address the key challenges of API particle sizing while meeting the rigorous demands of regulatory and quality frameworks. Building on decades of expertise in laser diffraction, it introduces advanced software features that elevate particle-sizing capabilities:

• Size Sure: Boosts confidence in routine measurements and method development.
• Data Quality Guidance: Provides actionable insights for real-world sample analysis.
• SOP Architect: Simplifies and standardizes method development for wet samples.

With the Mastersizer 3000+, you gain the tools and confidence to tackle the most complex particle-sizing challenges.

Morphologi range

Control particle size and shape with precision during formulation and scale-up. 

The Morphologi range delivers fully automated static image analysis. The Morphologi 4-ID combines automated static image analysis with Raman spectroscopy to deliver detailed chemical and morphological characterization of individual particles, even in complex samples. It also validates measurements from Mastersizer 3000+ for seamless integration into your workflow.

Insitec

Optimize manufacturing with real-time particle size analysis using the Insitec range. Designed for high-throughput environments, Insitec provides continuous laser diffraction monitoring for solids (Insitec Dry) and liquid suspensions (Insitec Wet). 

Capable of analyzing up to 20kg of solid-state compounds per hour, Insitec enables quick identification of deviations, turning potential batch losses into routine corrections, saving time and costs. 

Understanding the crystal structure of drug substances is essential for ensuring stability, solubility, bioavailability, and polymorphic consistency. X-ray diffraction provides the insights needed to optimize the solid form of active pharmaceutical ingredients (APIs), achieve stable drug formulations, streamline production, and ensure product quality across the drug product lifecycle.

If you doubt the homogeneity of your materials or have evidence of sample inconsistency, then you should explore the benefits of Morphologically-Directed Raman Spectroscopy. This technology combines analytical imaging with Raman Spectroscopy in the Morphologi 4-ID.

Aeris range

Aeris simplifies crystal structure analysis for monitoring polymorphism, solid form stability and crystallinity/amorphicity of drug substances. XRD data collected on Aeris can also be used for Limit of Detection (LOD) and Limit of Quantification (LOQ) assessments that support reliable analysis of polymorphic contaminations and pave the way for robust QC batch release testing. Aeris can support you throughout drug substance development through validation of solid form on solid 

• Easy to use: Compact, plug-and-play design fits any lab, no expertise required.
• Fast results: Obtain a full pattern to fingerprint active pharmaceutical ingredients (APIs) in under 5 minutes.
• High sensitivity: Detect minor components with confidence, ensuring product quality.

What’s more, OmniTrust software ensures 21 CFR Part 11 compliance, while Aeris’ modular design and vast analytical capabilities of HighScore software future-proof your investment. 

Empyrean range

For advanced crystallographic and polymorphic studies, Empyrean is the ultimate solution:

• Versatile applications: Supports XRPD at ambient and non-ambient conditions, high-throughput screening, various X-ray scattering techniques, , and imaging.
• Adaptable design: Customize your Empyrean with sample holders, optical modules, or advanced techniques.

Empyrean meets the needs of both research and manufacturing, providing tailored solutions for X-ray diffraction studies.

When you need to screen samples fast, X-ray fluorescence analyzers deliver highly accurate analysis of high-concentration samples, making them particularly useful for process chemists working on purification, catalyst scavenging, and synthesis optimization.

Energy-dispersive (ED) XRF is a fast, cost-effective, and user-friendly alternative to traditional ICP methods for screening elemental impurities in pharmaceutical samples, delivering reliable results that comply with USP <232,233> and Q3D.

Revontium™

Revontium is the world’s first compact ED XRF analyzer, delivering floor-standing power in a 0.4m² footprint.

• Streamlined operation: Touch-screen interface and high-capacity sample changer simplify workflows.
• Cost-effective: Reduce operating expenses with in-house elemental analysis.

Revontium enhances your elemental analysis capabilities, making it more efficient and accessible.

Epsilon Range

The Epsilon Energy Dispersive XRF (ED XRF) analyzers make in-house elemental analysis simple and cost-effective:

• Epsilon 1: Portable spectrometer with built-in software, minimal prep, and low running costs.
• Epsilon 4: Benchtop analyzer for high-throughput (10 samples/run), completing 20-element ICH-Q3D screenings in just 45 minutes.

Our decades of experience supporting customers and working with partners in the pharmaceutical give us a keen insight into the challenges you face throughout drug development and manufacturing processes. As a result, our analytical solutions are used by major pharmaceutical companies to support their processes from drug discovery to quality control, as well as in peer-reviewed research.

Our extensive portfolio of solutions covers every step of the drug development and manufacturing workflow, supported by a wide range of support services, from method development support to proactive instrument monitoring via Smart Manager.

Contact us to find out more about how we can support your solid-state characterization.