Pharmaceutical Elemental Impurities Analysis System

Energy Dispersive X-ray Fluorescence Spectrometer

Software Optimized for Pharmaceutical Analysis

PCEDX Pro Software

Analysis is performed using PCEDX Pro software. Easy-to-use operations enable fully automatic measurements, so even novices can feel confident. This highly functional software supports many quantitative calculations, including the calibration curve method, the fundamental parameters (FP) method, the thin film FP method, and the background FP method (patented by Shimadzu).

PCEDX Pro Software

FDA 21 CFR Part 11-Compliant System (Option)

The EDX-7000 is also compliant with FDA 21 CFR Part 11. With this option, user administration, system administration, and data management can be performed with LabSolutions.

PCEDX for Part 11 DB (Standalone Database Edition)

Contents

 

  • Media (PCEDX for Part 11 installer, LabSolutions DB connection kit, instruction manuals, PDF creation tool)
  • Software license installation manual

 

PCEDX for Part 11 CS (Client Server Edition)

Contents

 

  • Media (PCEDX for Part 11 installer, LabSolutions CS connection kit, instruction manuals)

 

FDA 21 CFR Part 11 Compliance Features Needed in Pharmaceutical Industry

The following functions compliant with FDA 21CFR Part 11 are provided.

 

  • Security Function
  • User Right’s Management
  • Validation Function
  • Operation and Audit Trail Log Output Functions
  • PDF Data Output

 

LabSolutions DB/CS Data Management - Higher Efficiency

Contents

All analytical data including data obtained from other analytical instruments is managed on a database on the server computer, allowing data to be loaded and managed on any computers on the network.

Pharmaceuticals Impurities Analysis Method Package (Option)

This package provides analysis methods to support the four elements in Class 1 as stipulated by ICH Q3D, the three elements in Class 2A, and five elements from among the Class 2B elements. Analysis is performed by creating a calibration curve with a specified standard mixture solution and solutions made by diluting it.

Pharmaceuticals Impurities Analysis Method Package

Contents

 

  • Conditions media (pharmaceuticals impurities analysis conditions file) (overlap correction measurement conditions file)
  • Instruction manual for pharmaceuticals impurities analysis (PDF format)

 

Analysis for Cd, Pb, As, Hg, Co, V, Ni, Pd, Ir, Rh, Ru, and Pt

This accommodates 12 important elements requiring risk assessment from among the 24 elements stipulated by the ICH Q3D.

Calibration curve conditions using the background internal standard correction method

This method corrects quantitative determination errors arising from differences in sample quantities, forms, and matrices.

Note: The standard mixture solution used for creating the calibration curve is not included in the package. Purchase the following separately.

SPEX CertiPrep (USA)

 

  • XSTC-2046 (Cd, Pb, As, Hg, Co, V, Ni)
  • USP-TXM 4 (Pd, Ir, Rh, Ru, Pt)

 

Efficacy of the Background Internal Standard Correction Method

With the heavy elements included in organic substances, even fluorescent X-rays generated from deep in the sample penetrate the sample and reach the detector. As a result, the intensity of the fluorescent X-ray changes depending on differences in the sample amount (sample depth). Accordingly, scattered rays (background) generated when X-ray irradiation from the X-ray tube strikes the sample are utilized for internal standard correction, thereby correcting quantitative determination errors due to the sample depth and form.

Element Material Cellulose
Sample Amount 2.0 g 1.0 g 0.5 g
Cd Without internal standard correction 10.3(0.9) 7.0(0.8) 5.1(0.6)
With internal standard correction 9.9(0.9) 10.5(1.1) 10.5(1.3)
Pb Without internal standard correction 10.5(0.5) 8.9(0.4) 6.2(0.2)
With internal standard correction 10.0(0.5) 9.3(0.5) 9.8(0.4)
Rh Without internal standard correction 11.6(0.8) 8.9(0.7) 6.9(0.6)
With internal standard correction 10.7(0.7) 10.4(0.8) 10.7(1.0)

Precautions Prior to Installing the Package

 

  • It may not be applicable for materials containing a large amount of additives, minerals or other inorganic components. Consign the analysis or perform other checks before installing the package.
  • Overlap correction measurements, dilution of the standard solution, and creation of the calibration curve are performed by the user in accordance with the instruction manual included in the package.

 

For Research Use Only. Not for use in diagnostic procedures.

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