21 New White Papers For Handheld-Xrf Instrument
With rapid, non-destructive screening analyses in laboratory quality, the Spectro xSORT handheld XRF instrument has definitely convinced users in many industries since its introduction in 2009. In four new white papers, Spectro now documents use of the compact specialist in environmental and compliance analysis as well as in the metal processing and metal trading industries. Environmental analysis plays a key role in fighting environmental contamination. The Spectro xSORT analyses waste, soil, wood and building material quickly and without sample preparation. With the shortest of measuring times, the instrument measures the contents of many important elements and is optimised for the highest of throughputs.
More and more laws around the world define maximum values for elements and/or element bonds in everyday products in order to minimize the effects of harmful substances. The Spectro xSORT recognises relevant elements such as lead, chromium, mercury, cadmium, bromine and many more. It delivers laboratory-quality measurement results within a few seconds and, as a non-destructive system, is suited to the screening of products that are intended for resale. Use of the wrong material in production and plant engineering can have grave consequences. The Spectro xSORT reliably identifies materials that cannot be optically or tactilely differentiated. The instrument determines the material grade at the press of a button and provides certainty to users in incoming inspections and shipping.
The sorting of scrap metal with the Spectro xSORT is performed in a flash. The instrument is ergonomic, enabling fatigue-free onsite use. Simple operation makes the robust Spectro xSORT practicable even for non-technical personnel.
Circle no. 46
ADVERTORIAL On-line Estimation of the API Content in Tablets Using NIR Spectroscopy
Process analytical technology (PAT) has been mentioned over the last few years, the aim is to design and develop well understood manufacturing processes that will consistently ensure a predefined quality at the end of the manufacturing process. Near Infrared (NIR) spectroscopy is one of the most powerful tools for PAT due to its major advantages: it is a fast and nondestructive analysis method. To address this field Buchi cooperates with competent and well established partners in order to deliver the best solution to our customers. Starting with the verification of material‘s identity up to on-line tablet analysis and final release tests Buchi technology covers all. This short report concentrates on the on-line analysis of tablets by NIR transmission measurements. During tabletting it is essential to monitor and control all quality relevant parameters like compression force, weight, thickness, diameter, hardness and API content. Until now practically only compression force and the physical parameters are monitored on-line and are used partly for a control loop. The API content is normally determined using HPLC after finishing the batch. This procedure provides a too late determination of out of specification
batches. During the last years NIR measurements have been used replacing HPLC, which are much faster and deliver reliability and accuracy comparable to HPLC. However the measurements are still performed after finishing the production of the batch. In order to receive early fault detection, the API content during manufacturing needs to be estimated on-line. The obvious benefits are improved quality as well as real time process information, understanding and control.
With NIR spectroscopy tablets can be investigated either in reflection or in transmission mode. Modern tablets often involve multi-layer or other complex designs. In order to collect the information from the complete cross-section transmission measurements are required. This goal is achieved by integrating the robust Buchi NIRFlex N-500 FT-NIR spectrometer with the Solids Transmittance module into the proven Checkmaster from Fette Compacting (Schwarzenbek, Germany). As NIR spectroscopy is a secondary analytical method, a calibration is needed. Proper calibration curve requires the measurement of a considerable number of samples, from which the API contents have been determined by a primary analytical method (HPLC). For efficient calibration development a laboratory based NIR spectrometer will be used. During an extensive application study calibrations of a pharmaceutical manufacturer were developed on a laboratory spectrometer and transferred to the on-line system. Figure 1 shows the calibration curve indicating the excellent agreement between NIR and HPLC reference values. Figure 2 demonstrates the outstanding calibration transfer from a laboratory based NIR spectrometer to the on-line “NIR Checkmaster” system.
Both figures demonstrate that NIR is capable of delivering reliable and accurate results in a laboratory as well as an on-line environment.
Circle no. 47 NIRFlex® Additional information is available on
www.buchi.com > NIR Solutions
BÜCHI Labortechnik AG 9230 Flawil / Switzerland T +41 71 394 63 63
www.buchi.com
Figure 2: Comparison of the results for 60 identical tablets estimated on the laboratory system (blue) and the on-line system (magenta)
NIR Solutions for PAT
BÜCHI PAT solutions are essential components in tablet manufacturing. With our well established partners we offer highest synergies, attractive benefits and quick returns. Fette’s NIR Checkmaster integrates the NIRFlex®
N-500 to analyse physical parameters and API content online
Sotax’ HT 10 and Q-Doc software combine physical parameters and API content with release test data Our LIMS interface transfers data and results into systems like mySAP™ PLM or Ciwos®
from CS Engineering
Raw material ID supported by numerous proven, recognized algorithms and comprehensive spectral libraries Compliance with GMP requirements, international pharmacopoeias and 21 CFR Part 11 rules
Figure 1: Calibration curve showing the API content estimated by NIR vs. the HPLC data.
Quality in your hands Circle no. 48
INTERNATIONAL LABMATE - APRIL/MAY 2010 - CHROMATOGRAPHY & SPECTROSCOPY
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68
