Pharmaceutical XRD Testing

Ensure your pharmaceutical products' safety, efficacy, and regulatory compliance with precise X-ray Powder Diffraction testing. When you need accurate crystalline structure analysis with minimal sample quantities, Element's 30+ years of expertise, advanced Empyrean technology, and dual-geometry capabilities deliver critical insights without sample preparation, accelerating your development timelines while ensuring data integrity.

X-Ray Diffraction of Pharmaceuticals
I'm trying to...

What is Pharmaceutical XRD Testing testing at element ?

X-ray Powder Diffraction (XRPD) is an analytical technique that identifies and characterizes crystalline materials by measuring how X-rays diffract through crystalline structures in powder samples. At Element, we leverage this powerful technique as leaders in the field of X-ray Powder Diffraction (XRPD) analysis to provide detailed crystallographic information crucial for pharmaceutical development, formulation stability, and regulatory compliance, helping you understand your products at the molecular level.

Element life sciences testing expert in lab

What can Element offer you for Pharmaceutical XRD Testing?

Materials We Test

Our comprehensive XRPD testing capabilities extend across a wide range of pharmaceutical materials, from raw APIs to finished dosage forms. We specialize in analyzing challenging samples including those prone to preferred orientation effects such as needle or platelet structures. Our expertise allows us to test with minimal sample amounts—less than 10mg—making us ideal for valuable or limited-quantity materials.

Key Tests Offered

We provide a comprehensive suite of X-ray diffraction analyses tailored to pharmaceutical needs. Our services include:  

  • Powder Diffraction 
  • Phase Identification 
  • API Limit Testing 
  • Percent Crystallinity 
  • Identification of Pharmaceutical Powders 
  • Foreign Phases Analysis 
  • Stability Projects to Ensure Stable Crystalline Structure 
  • Quantitative Analysis of Mixtures of Crystal Forms 
  • Analysis of Inorganic Products Such as Corrosion Products (e.g. Ceramics and Clay) 

Solutions Offered

Element offers both reflection and transmission geometry XRPD methods, giving you flexibility based on your specific sample requirements. Our transmission geometry capability is particularly valuable for solving problems in traditional reflection geometry when analyzing pharmaceuticals, proteins, polymers, powders prone to preferred orientation effects (such as needles or platelets), liquid dispersions or slurries, and air sensitive or hazardous materials. You'll benefit from our ability to analyze samples without preparation—tablets, capsules, creams, and suspensions can be tested directly, streamlining your process. 

Cutting-edge Equipment We Use

We employ the Malvern Panalytical third-generation Empyrean X-ray diffractometer, providing exceptionally high-resolution diffraction patterns efficiently. This state-of-the-art instrument includes the latest crystallographic database for reliable identification of unknown compounds and is complemented by CFR Part 21 compliant software—ensuring both accuracy and regulatory acceptance.

Standards we test to and materials we test

These are our most prevalent requests. Don't see what you're looking for? Contact us!
  • United States Pharmacopeia (USP) methods
  • European Pharmacopoeia (Ph. Eur.) methods
  • International Conference on Harmonisation (ICH) guidelines
  • FDA regulatory requirements
  • GMP/GLP compliance standards
  • Your Challenges, Our Solutions

    Checklist

    Regulatory Documentation Needs

    Element's pharmaceutical XRPD testing delivers comprehensive crystallographic data packages that satisfy even the most stringent regulatory requirements. Our CFR Part 21 compliant system ensures data integrity throughout the testing process, providing you with defensible results for successful submissions.
    Checklist

    Tight Development Timelines

    Our third-generation Empyrean diffractometer accelerates your testing cycle while maintaining exceptional data quality. With direct sample analysis capabilities and minimal material requirements, you'll meet critical development milestones efficiently without compromising results.
    Checklist

    Accurate Phase Identification

    Element's advanced instrumentation and comprehensive crystallographic database enable precise identification of crystal forms and phases critical to your products' efficacy and stability. Our dual geometry approach overcomes orientation challenges that might otherwise compromise accurate characterization.
    Checklist

    Limited Sample Availability

    When working with expensive APIs or limited research quantities, our capability to analyze samples as small as 10mg ensures you can conduct comprehensive testing without depleting valuable materials—providing complete characterization data even with minimal sample amounts.

    Why Choose Element

    Element scientist in white lab coat working in life sciences testing laboratory

    Pharmaceutical Market Leaders

    Over 30 years of specialized experience in the global pharmaceutical industry.

    Minimal Sample Requirements

    Capable of analyzing less than 10mg of powder while maintaining exceptional data quality.

    Dual Analysis Methods

    Offers both reflection and transmission geometry to overcome sample-specific challenges.

    No Sample Preparation

    Analyze tablets, capsules, creams, and suspensions directly without preparation steps.

    30+
    years

    in pharmaceutical analysis

    <10mg
    minimum

    sample requirement

    3rd
    generation

    Empyrean diffractometer

    21
    CFR

    Part 11 compliant software
    Element laboratory scientist placing raw materials sample in test chamber for controlled testing conditions

    Frequently asked questions

    What is transmission geometry XRPD and when should it be used?

    Transmission geometry XRPD is a specialized approach where X-rays pass through samples rather than reflecting off surfaces. This method is particularly valuable for pharmaceuticals, proteins, polymers, and materials with orientation effects like needle or platelet structures. It's also ideal for analyzing liquid dispersions, slurries, and air-sensitive or hazardous materials that pose challenges in traditional reflection geometry.

    How much sample is required for XRPD analysis?

    Our advanced instrumentation can analyze samples as small as 10mg or less while still generating high-quality diffraction patterns. This makes our service ideal when testing valuable APIs, limited research quantities, or expensive materials during development phases. 

    How does Element ensure regulatory compliance with XRD testing data?

    Element uses CFR Part 21 compliant software throughout the testing process, ensuring data integrity and traceability required by regulatory agencies. Our comprehensive documentation approach and 30+ years of experience in pharmaceutical testing means we understand exactly what regulators need to see in your submissions.

    map

    Explore our global network of labs and find your nearest location

    VIEW ALL LOCATIONS

    Related services

    Element pharmaceutical testing scientist with laboratory equipment for drug development and compliance

    Pharmaceutical Testing Services

    Element leads the way in pharmaceutical testing services, delivering trusted expertise from prototype to analysis and finished product. With 150+ global pharmaceutical experts and 30+ years of experience.

    Pharmaceutical Testing Extractables and Leachables

    Extractables and Leachables Testing Services

    Element provides tailored extractables and leachables testing (E&L) studies to ensure patient safety and compliance with regulatory requirements.

    Pharmaceutical raw materials testing

    Raw Material, In-Process & Lot Release Testing services

    Our raw material and finished product testing bring peace of mind to manufacturers of drug products ensuring the safety, purity, and quality of both starting materials and manufactured products.

    Speak to our team of experts

    AMERICAS

    Toll free from US lines

    +1 888 786 7555

    EUROPE

    Contact our Central Team
    UK

    Freephone from UK

    +44 808 234 1667

    Germany

    Freephone from Germany 

    +49 800 000 5137

    MIDDLE EAST

    Toll free from UAE

    +971 800 353 6368