This webcast offers expertise to help you achieve confidence and compliance in your XRD workflow for pharmaceutical analysis. It covers guidelines for XRD sample preparation as well as different measurement strategies you can use while complying with even the most recent regulatory requirements.
Security and integrity in your XRD data
Confidently secure your laboratory data and its integrity using the Thermo Scientific SolstiX XRD Software with Security Suite. This security package is available with our complete Thermo Scientific ARL EQUINOX X-ray Diffractometer range and enables 21 CFR Part 11 compatibility.
SolstiX XRD Software with Security Software features:
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- Full-system access control to authenticate users
- True digital signatures to record responsibility and provide data integrity protection
- Traceability with complete audit trails
- Original data save option with flexible record storage and retrieval
Software logs change to files associated with the software, even when SolstiX Software itself is not running because the system use and file event logging is output in a custom Thermo Fisher log within the Microsoft® Event Viewer.
Note: Thermo Scientific Security Administration Server is responsible for giving system administrator control over software access, policies and digital signature meanings in an intuitive interface. This server can be run stand-alone on your spectrometer workstation or as a server application to administer SolstiX Software on one or all the systems in your facility.
Thermo Scientific ARL EQUINOX 100
Get a dedicated XRD instrument designed for QA/QC, academic, and routine X-ray diffraction applications with the compact, affordable ARL EQUINOX 100 X-ray Diffractometer.
From drug discovery and preformulating studies to the efficient scaling up in the manufacturing process in the plant and finally through QA/QC validation, X-ray diffraction (XRD) is a vital analysis method in the characterization of different physico-chemical properties of the active pharmaceutical ingredient (API).
- Crystallography and crystal structure determination
- Phase analysis and polymorph screening
- Crystallinity determination
- Solid dosage forms and bioavailability
- Stabilities studies
- Manufacturing and production
- Process control
XRD is a gold standard method and required technique in the determination of polymorphic and salt screening, percent of crystallinity and stability/reactivity studies of the final API.
- Structural characterization technique
- Nondestructive technique
- Small amount of sample
- Unique diffraction patterns and quick response
- Analysis on mixtures as well as amorphous content
- Easy determination of induced structural changes
Click to enlarge. A complete XRD diffractogram obtained in real time with all required security and integrity required by FDA 21 CFR Part 11 regulation.
Webinar: Capable and Compliant XRD in Pharmaceutical Analysis
Predicting the crystalline nature of APIs with a novel in-line X-ray technique: InsituX
Hear Prof. Gérard Coquerel, the University of Rouen Normandy, illustrate how the precise identification of solid phases and their crystallinity are important for the design of drying, the storage conditions, and the repeatability of the solid transformations regarding APIs, as well as the identification of non-stoichiometric solids and the possible presence of polymorphs of hydrates and anhydrates.
Analysis of polymorphism in pharmaceuticals using XRD technique
In line with our mission to enable our customers to make the world healthier, cleaner and safer, Thermo Fisher Scientific is a reliable partner for X-ray diffraction analysis for Pharmaceutical R&D and QA/QC applications..
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