Company Overview
PANalytical is the world's leading supplier of analytical instrumentation and software for X-ray diffraction (XRD) and X-ray fluorescence spectrometry (XRF), with more than half a century of experience. PANalytical was founded in 1948 as part of Philips and was formerly known as Philips Analytical. It employs around 900 people worldwide and has its headquarters in Almelo, the Netherlands.
Both X-ray powder diffraction (XRPD) and X-ray fluorescence (XRF) spectroscopy are recognized as valuable techniques in many areas of drug discovery, development and manufacture.
X-ray powder diffraction
XRPD is used to non-destructively determine the crystallographic constitution of samples, such as crystal structure, polymorph or hydrate forms, changes in crystalline state of active ingredients due to processing or non-ambient conditions, presence of crystalline impurities (in some cases down to 0.05%), and determination of the crystallinity or the crystallite size of a compound. XRPD data on a compound or drug is also required for new product registration and patent application/protection.
X-ray fluorescence
XRF spectroscopy is a non-destructive technique, which requires simple or even no sample preparation. It detects and quantifies major and minor elements in fillers, lubricants, coatings and other excipients down to sub-ppm levels. XRF can also be applied to the high precision quantification of catalyst residues present in active ingredients or final drug products.
PANalytical has a range of systems for X-ray analysis within the pharmaceutical industry. All are designed to meet regulatory requirements, including suitability for use in a 21 CFR Part 11 compliant laboratory environment.
Quick Facts
PANalytical Inc.
117 Flanders Road
Westborough, Mass. 01581
| Web: | www.panalytical.com |
| Email: | info@amec.panalytical.com |
| Phone: | 508-647-1100 |
| Fax: | 508-647-1115 |
- White Papers/Case Studies (3)
- Analyst Reports (0)
- Webcasts (0)
- Multimedia (0)
- Application Notes (15)
- Product Information (3)
- Supporting the Pharmaceutical Industry with 21 CFR Part 11 Compliance Readiness by PANalytical Inc.
The purpose of this document is to describe how PANalytical systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the United States’ FDA.
- QbD and Detecting Crystal Polymorphs by PANalytical Inc.
No longer just a fingerprinting method, X-Ray Powder Diffraction is becoming a user-friendly PAT tool.
- A Technological Solution for Combating Counterfeit Drugs by PANalytical Inc.
This white paper examines the issue of counterfeit drugs, reviewing the various types produced and the nature and range of the damage they cause. The report then focuses on analytical methods for tackling the problem, in particular the use of X-ray powder diffraction (XRPD).
- A Complete Walk-Up System Solution for X-Ray Powder Diffraction by PANalytical Inc.
The Cubix Walk-Up systems comes with the security of 21 CFR Part 11 supporting software, and the possiblity of working in conjunction with many LIMS systems.
- X-Ray Solutions for the Pharmaceutical Industry by PANalytical Inc.
This brochure describes the practical advantages of XRPD in the pharmaceutical industry, PANalytical's detector technology and the innovative design of PreFIX optics and stages that makes application switching straightforward and alignment free, the wide range of applications for the physical characterization of pharmaceutical solids, and solutions for meeting the requirements of a highly regulated environment.
- Quantitative Evaluation Of Pharmaceutical Solids by PANalytical Inc.
This research investigates combinations of optics and diffraction methodologies that would allow an accurate quantification of an API in a typical pharmaceutical oral dosage form.
- Quantitative XRD: Detection of Low Amounts of Crystalline Impurities for ... by PANalytical Inc.
In this example application, standard samples of Form 1 of an API were spiked with low levels of the polymorph Form II. XRPD was used to calibrate an analysis, programmed in PANalytical's X'Pert Industry software, which could then be used for manufacturing process control to ensure that the right polymorph crystallized in the process steps.
- Crystallite Size Determination by PANalytical Inc.
This note describes the use of Rietveld method for determining crystallite sizes of pharmaceutical powder samples.
- X-Ray Diffraction in Biomedical Research by PANalytical Inc.
In this application note, thin film XRD was employed for qualitative analysis of the chemical and biological properties of biomedical, electrosprayed calcium phosphate coatings.
- Transmission Diffraction: Measurement and Unit Cell Refinement of Lysozyme by PANalytical Inc.
In this research, transmission experiments were performed on a hen egg-white lysozyme sample.
- Temperature and Humidity Controlled XRD by PANalytical Inc.
The temperature controlled humidity system for X-ray diffraction analysis was applied to measure the influence of temperature and humidity on 4-epi-oxytetracycline in this application note.
- Crystallinity Determination by PANalytical Inc.
This note compares the use of three different methods- X-ray diffraction (XRD), near infrared spectroscopy (NIRS) and differential scanning calorimetry (DSC)-for quantifying small amounts of amorphous material in a crystalline matrix, and vice versa.
- X-Ray Diffraction on Aerosol Drugs by PANalytical Inc.
In this note, an X-Pert PRO MPD system equipped with an X'Celerator detector was used to analyze the crystal structure of Ventolin and to quantify small amounts delivered by a pressurised metered dose inhaler.
- High-Resolution, High Throughput XRPD by PANalytical Inc.
High throughput screening is not commonplace in pharmaceutical development. This application note describes the use of a PANalytical X-ray powder diffractometer for high throuput, high-resolution polymorph screening.
- Analysis of Air Filters According to EPA Method 10-3.3 by PANalytical Inc.
<P>This application study demonstrates the performance of the Epsilon 5 EDXRF analyzer according to the EPA method 10-3.3, with the elemental range extended from 44 to 55 elements.</P>
- Application Study: The Analysis of Pd in Pharmaceutical Materials Using the ... by PANalytical Inc.
The Epsilon 5 is a high performance energy dispersive X-ray fluorescence spectrometer specifically designed to achieve the lowest possible LLD's for heavy trace elements such as Cd, Pb, As, precious metals and the lanthanides.
- Trace Element Analysis of Organic-Rich Samples Using Axios with Pro-Trace by PANalytical Inc.
Axios with Pro-Trace software and standards make up a unique solution for trace analysis in a wide variety of organic-rich materials.
- Determination of Fe in Milk Powder by PANalytical Inc.
Milk is a source of essential nutrients for humans, therefore the elemental analysis of milk powder is very important. Of all the metals, iron is one of the most known as a nutrient. Measurements in this study were performed using the MiniPal 2 benchtop EDXRF spectrometer.
- X'Pert Pro Alpha-1 by PANalytical Inc.
The X'Pert Pro Alpha-1 diffraction system is suitable for solving structures from powder data, searching for polymorphic phases where peak overlap is a hinderance, studying nanomaterial peak profiles to extract crystallite size, dislocation densities and preparing materials for synchrotron beam time.
- High Throughput Diffraction by PANalytical Inc.
PANalytical's X'Pert PRO MPD, equipped with automated sample changer and high speed, high resolution X'Celerator detector can already measure hundreds of full scans every day.
- X'Pert PRO MPD: Multi-Purpose X-Ray Diffractometer by PANalytical Inc.
The X'Pert PRO MPD x-ray powder diffractometer offers a variety of optics, sample stages, changers and detectors allowing the optimal combination of resolution and data collection speed for every sample.
