The Japanese Pharmacopoeia infrared absorption spectrum measurement method was linked to the European Pharmacopoeia 4.0 in Revision 14, Supplement 1.With the release of the European Pharmacopoeia 5.0, differences with the Japanese Pharmacopoeia again occurred however, it is likely that re-linking of the standard will occur in the near future with another revision. The Japanese Pharmacopoeia is periodically revised, often with a view to linking it with the pharmacopoeia of other countries. On the other hand, in Japan, compliance with the Japanese Pharmacopoeia is fundamental. The European Pharmacopoeia is, as the name indicates, the compilation of standards that apply to the European Union (EU).When products are shipped into the EU, they often require instrument validation complying with the European Pharmacopoeia 5.0. Standardizing Validation Standards of Japanese Pharmacopoeia and European Pharmacopoeia 5.0 If the difference in absorbances is within the permissible range at all three specified points, a pass rating is assessed. The program assesses whether or not the difference between the two measurement results is within the permissible range. Polystyrene film is measured twice, and the absorbance values are compared at three specified points. For example, the absorbance of the 2849.5 cm -1 peak is about 1 ABS (about 10 % transmittance), so the absorbance fluctuation (вђ.03 ABS) corresponding to the вђ.5 % transmittance fluctuation is considered the permissible range.

The permissible range according to the Japanese Pharmacopoeia is 0.5 %, expressed in transmittance however, in the validation program that supports the European Pharmacopoeia 5.0, transmittance values that fluctuate вђ.5 % from the transmittance at the test wavenumber are converted to absorbance, and are then evaluated with respect to the permissible range.

The test procedure is the same in the validation program for both the Japanese Pharmacopoeia and European Pharmacopoeia 4.0. If the difference in peak wavenumbers is within the permissible range at all three specified points, a pass rating is assessed.ДЄlthough this test is not included in the European Pharmacopoeia 5.0, this is regarded as a test item due to standardization with the Japanese Pharmacopoeia.

Polystyrene film is measured twice, and the peak wavenumbers are compared at three specified points. A pass rating is assessed if each of the wavenumber measurement values is within the specified variance.ДЄlthough this test is not included in the European Pharmacopoeia 5.0, this is regarded as a test item due to standardization with the Japanese Pharmacopoeia. A pass rating is assessed if each of the absorbance values is equal to or greater than the respective criterion value. When the measured intensity is equal or larger than the criterion value, the test is passed. This test compares the intensity of the power spectrum at a specified wavenumber to the criterion values. In both the Japanese Pharmacopoeia and European Pharmacopoeia 4.0, instrument performance evaluation is based on the 5 test items: (1) power spectrum, (2) resolution, (3) wavenumber accuracy, (4) wavenumber repeatability and (5) absorbance reproducibility.ДЄlthough not included in the European Pharmacopoeia 5.0, this test is used to evaluate the most basic performance of the FTIR. The validation program supporting the European Pharmacopoeia 5.0 is included in IRsolution Ver. Validation Program Supporting European Pharmacopoeia 5.0

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