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NIRFlex-Solids-Transmittance

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


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 - 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.

 


 

  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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968 Rama4 Road, Silom, Bangrak, Bangkok 10500 THAILAND
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