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Specifi cations
Instrument Standardization at each regional pharmacopeia (factory option)
JP
Calibration
Particle size calibration using the calibrated particles of 1.3 to 100 µm
which have domestic and international traceability have a margin of
error of less than 3%. However, our own specifi ed method will be
carried out for the calibration of less than 4 µm.
Performance-Test
Sample volume accuracy test
Flow rate accuracy test
Particle counting accuracy test, threshold accuracy test and sensor
resolution test using Clintex (Particle Count Reference Standard
Suspension), which is manufactured by JSR.
USP
Calibration
Particle size calibration using the calibrated particles of 1.3 to 100 µm,
which are traceable and NIST standard reference materials. However,
our own specifi ed method will be carried out for calibration of less
than 4 µm.
Performance-Test
Sample volume accuracy test
Flow rate accuracy test
Counting accuracy test and Ratio value test using USP-PC-RS
Sensor resolution test using calibrated particles of 10 µm.
EP
Calibration
Applied to JP or USP*
Performance-Test
Applied to JP or USP*
* EP has no regulations about Calibration and Performance-Test
Sample container size
Maximum size (diameter)
Beaker 300 mL (JIS R 3503)
Maximum height Tall beaker 200 mL (JIS R 3503)
Sample container plate
Internal diameter 77 mm, depth 5 mm
Sample fl uid temperature range
+15 to +30°C (no condensation on fl ow cell)
Содержание KL-04
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