New Tools Target Speed, Simplicity, and Compliance

April 25, 2016

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-05-04-2016, Volume 11, Issue 5

Instruments are introduced for elemental impurity analysis and materials identification.

New compendial guidelines, demands for faster and accurate materials analysis, and the need for sophisticated, yet simple-to-use, instruments are shaping the features and functionality of new analytical instruments. The descriptions here are sourced from instrument manufacturer press announcements.

Elemental impurities analysis
As laboratories gear up for implementation of the new US Pharmacopeia elemental impurities guidelines, instrument manufacturers are responding with new systems for analysis.

The Thermo Scientific iCAP RQ inductively coupled plasma mass spectrometry (ICP-MS) spectrometer features intelligent workflows, universal interference removal, and automated sample handling accessories for trace elemental analyses. The instrument can perform unattended sample analysis to maximize sample throughput and productivity in the laboratory.

Features include a quick connect sample introduction system, open geometry architecture for easy peripheral connection, and compatibility with automation and sample handling systems. The Thermo Scientific Qtegra Intelligent Scientific Data Solution (ISDS) software, a shared software approach, provides control and data processing for a range of elemental and isotopic analysis technologies (1).

The ICPMS-2030 inductively coupled plasma mass spectrometer from Shimadzu Scientific Instruments features analysis functions and proprietary cost-reducing capabilities, for efficient, sensitive trace element analysis, the company reports.

The system’s Development Assistant automatically selects the optimal mass and internal standard for the target elements and suggests concentration ranges for calibration curves. The Diagnosis Assistant identifies the presence or absence of mass interference based on qualitative analysis. A Mini-Torch system reduces the amount of argon gas needed to generate plasma; ECO mode minimizes the flow rate and power consumption during standby. The instrument can operate on 99.95% purity argon gas, instead of the more expensive 99.999% argon gas generally used.

The instrument suppresses molecular interference through optimization of the collision cell and internal ion path geometry (2).

SPECTRO XEPOS spectrometers from SPECTRO Analytical Instruments feature energy dispersive X-ray fluorescence (ED-XRF) technology for multi-elemental analysis of major, minor, and trace element concentrations. The analyzers are designed to handle rapid screening elemental analysis and support product quality control for pharmaceutical manufacturing. The TurboQuant II software analyzes unknown liquids, powders, or solid samples.

Four versions are available, enabling users to prioritize their selection according to measurement speed, precision, or groups of targeted elements in specific matrices (3).

Materials identification
The demand for rapid identification of pharmaceutical raw materials, and an April 1, 2016 effective date for the European Pharmacopoeia (Ph. Eur.) Chapter 2.2.48, which sets acceptable Raman wavelength shifts and associated tolerances for benchtop and handheld Raman instruments, has prompted innovations in these devices.

Rigaku Analytical Devices’ Progeny 1064nm handheld Raman analyzer is compliant with the Ph. Eur. calibration standards. The device overcomes sample-induced fluorescence interference through the use of a 1064-nm excitation laser, which enables measurements to be taken through packaging. The device facilitates regulatory compliance by providing a IQ/OQ/PQ protocol package, compliant 21 Code of Federal Regulations Part 11 digital signatures, and an integrated camera for barcode reading to ensure error-free data entry (4).

The Thermo Scientific TruScan RM Analyzer for raw material identification and finished product inspection performs through sealed packaging and is compliant with 21 CFR Part 11 guidelines. A new chemometrics package that integrates with the analyzer allows users to build customized models for both qualitative and quantitative sample predictions.

The TruTools package leverages Eigenvector Research Inc.’s SOLO standalone chemometrics software. Advanced TruScan RM users can customize acquisition parameters, including number of scans, exposure time, and laser power, then export the scan data. These data are imported into SOLO, where users can build custom models that can then be deployed onto the TruScan RM handheld analyzer (5).

Raman microscope
Renishaw has added Live Track focus tracking technology to the inVia Qontor Raman microscope, enabling the analysis of samples with uneven, curved, or rough surfaces. The microscope allows users to acquire accurate and reproducible spectra from samples with extensive topographic variations. The focus is maintained in real time during data collection and white light video viewing, removing the need for manual focusing, pre-scanning, or sample preparation, the company reports.

The LiveTrack technology provides continuous feedback to the sample stage, which adjusts to follow the height of the sample. This ensures the laser maintains focus during data collection and when manually moving the sample during white light video viewing. Optimum focus is maintained across uneven, sloping, or dynamic samples, limited only by the maximum travel of the stage (6).

Other instrument introductions
A line of differential scanning calorimeters from TA Instruments--the Discovery DSC2500, DSC250, and DSC25--feature enhanced sensing technologies for improved performance in baseline flatness, sensitivity, resolution, and reproducibility, the company reports.

The instruments feature the TA Fusion Cell, which incorporates design concepts from the Q-Series and first generation Discovery DSC, and patented Tzero technology. Other features include a standard app-style user interface, TRIOS software, and automated calibration and verification routines to improve laboratory work-flows and productivity. The DSC2500 comes standard with all options, including a linear autosampler that allows for assigning sample and reference pans to any combination of the available 54 positions. The T4P heat flow technology is capable of making and storing heat capacity measurements in a single run. The DSC250 is a research-grade DSC that includes Tzero technology. The DSC25 is a general purpose DSC for research, teaching, and quality control laboratories (7).

The Litesizer 500 from Anton Paar determines the size and stability of nanoparticles and submicroparticles in liquids and how they change with time, pH, temperature, and concentration. The instrument determines particle size, zeta potential, and molecular mass by using light-scattering technology, in combination with transmittance measurements.

Users can input parameters and view results and analysis on a single page. The patented cmPALS technology produces zeta petential measurements with high accuracy in a short measurement time, according to company literature. The technology allows the modulator to make large movements, resulting in the use of shorter measurements and lower electric fields, reducing the effects of electrode fouling and deterioration. Algorithms in the firmware technology allow users to resolve several different particle sizes in a single suspension (8).

1. Thermo Fisher Scientific, “New Instruments and Software Designed to Improve Trace Elemental Analysis,” Press Release (Atlanta, GA, March 7, 2016).
2. Shimadzu Scientific Instruments, “Shimadzu’s New Inductively Coupled Plasma Mass Spectrometer (ICP-MS) Offers Outstanding Reliability, Exceptional Ease of Use, and the Industry’s Lowest Operating Costs,” Press Release (Columbia, MD, March 7, 2016).
3. SPECTRO Analytical Instruments, “New SPECTRO XEPOS Spectrometers Redefine ED-XRF With Exceptional New Levels of Elemental Analysis Performance,” Press Release (Kieve, Germany, Jan. 19, 2016).
4. Rigaku Analytical Devices, “Rigaku Analytical Devices Supports Pharmaceutical Industry with Compliance to New Raman Calibration Standards,” Press Release (Wilmington, MA, April 1, 2016).
5. Thermo Fisher Scientific, “Raman Raw Material Analyzer for Pharmaceutical Industry Integrates New Chemometrics Capabilities,” Press Release (Atlanta, GA, March 7, 2016).
6. Renishaw, “Renishaw Launches the New inVia Qontor Confocal Raman Microscope,” Press Release (March 4, 2016).
7. TA Instruments, “TA Instruments Introduces 3 New Discovery DSC Systems,” Press Release (New Castle, DE, March 7, 2016).
8. Anton Paar, “Anton Paar Launches the Litesizer 500: Particle Analysis by Light Scattering,” Press Release (March 8, 2016).