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NIRFlex Solids Transmittance
With NIRFlex Solids Transmittance, Buchi offers a powerful tool to fulfill a major request described in the pharmacopoeias to ensure consistency of dosage units in tablets
With NIRFlex Solids Transmittance, Buchi offers a powerful tool to fulfill a major request described in the pharmacopoeias to ensure consistency of dosage units in tablets - each unit in a batch should have an active ingredient content within a narrow range around the label claim. Unlike traditional time-consuming and costly HPLC methods, where only the active content is determined, the Buchi NIRFlex N-500 FT-NIR spectrometer offers a speedy, efficient, and non-destructive method with the ability to determine additional parameters simultaneously.
With FT-NIR, these kinds of measurements can be performed, using reflectance or transmittance techniques. Reflectance measurements primarily collect information from the surface area only. To get complete sample information it is necessary to perform transmittance measurements, especially for coated or multilayer tablets.
- NIRFlex Solids Transmittance is the latest addition to the range of sampling options for NIRFlex N-500. It is optimized to perform transmission measurements of solid dosage forms, like tablets or capsules, in a very simple and convenient way.
Diffuse transmission measurements are very demanding applications, because only a very small part of the incident light is transmitted. Therefore care must be taken for good signal-to-noise ratio. The design of NIRFlex Solids Transmittance and its optimized detector ensure the best performance. NIRFlex Solids Transmittance uses a low energy source, which avoids any overheating of the samples, therefore enabling the investigation of temperature sensitive pharmaceutical active ingredients (API).
All typical samples like tablets, hard gelatin capsules, powders or soft gelatin capsules including semi-liquids or oily liquids can be measured with the same measurement option: NIRFlex Solids Transmittance. The extremely high dynamic photometric range of the system - one of its outstanding features - allows the generation of spectra with an optimized signal-to-noise ratio for all sample types. In addition, the sample plates are specially designed and coated to prevent stray light caused by light passing around the side of the tablets. All sample plates are customized for optimum measurement conditions for every kind of tablet.
The autosampler accepts up to thirty samples with a diameter of up to 12mm. For samples larger than 12mm, 10-place sample plates are available. The robust design of the measurement cell, with its fixed detector position and the direct drive of the sample plate assure high reproducibility and extremely long lifetime. The legendary robustness of Buchi NIR spectrometers guarantees seamless calibration transfer from one system to another. As a result, method development can be easily centralized. -
Content Uniformity Test (CUT)
In pharmaceutical tablet production and quality control, one of the most important measurements is testing the “Uniformity of Dosage Units” as requested by pharmacopoeias. NIRWare includes the most recent procedures and formulae according to the US Pharmacopeia, the European Pharmacopoeia and the Japanese Pharmacopoeia. The content uniformity test indicates the degree of uniformity in the amount of the drug substance of the blend from the assay of a defined number of tablets (typically 10). This test is required for batch release.
The Content Uniformity Test can be activated and configured in the NIRWare Application Designer. The procedure described in the pharmacopoeias is fully implemented and the resulting report summarizes the statistical results and parameters of the test.
Technical data of NIRFlex Solids transmittance
| Spectral range | 800 - 1'660 nm (default 870 - 1'660nm) 12'500 - 6'000 1/cm (default 11'520 - 6'000 1/cm) |
| Resolution | 8 1/cm (Boxcar Apodization) |
| Photometric dyn. range | 0 - 6 AU |
| Photometric linearity | The "addition of filter technique" has been used. A 2% transmission filter and wavelength standard (rare earth oxide mixture) were used for the addition. Both filters were measured individually and together in series. the addition of the individual measurements has been compared with the measurement of both filters in series. The difference had been <2 x 10-7 T at 7'876 1/cm |
| Wavelength accuracy | +/- 0.2 1/cm (measured with HF gas cell at ambient temperature) |
| Wavelength precision | +/- 0.2 1/cm (measured with HF gas cell at ambient temperature) |
| Number of scans/sec | 2 - 4 |
| Signal-to-noise ratio | (rms for spectral segments of 300 1/cm in the range of 10'100 - 6'500 1/cm) |
| open beam | mean 2 * 10-5 AU (16 scans; 8 1/cm; Blackman apodization) |
| 5mm Spectralon | mean 10 * 10-5 AU (64 scans; 8 1/cm; Blackman apodization) |
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NIRFlex N-500 Solids Transmittance
NIRFlex N-500 Pre-calibrated applications
Bergman AS • Postboks 364 2001 Lillestrøm • Tel: +47 63 83 56 00 • Faks: +47 63 83 56 10 • info@bergman.no service@bergman.no • Besøk: Slynga 2, 2005 Rælingen • Varelevering: Jogstadveien 21, 2007 Kjeller.