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Model Number |
EP2002 |
ITEMS STANDARD
DESCRIPTION: WHITE OR YELLOWISH-WHITE CRYSTALLINE POWDER
IDENTIFICATION: IR AND HPLC SPECTRUM CONCEDE WITH STANDARD
APPEARANCE OF SOLUTION: CLEAR AND NOT MORE INTENSELY COLORED THAN RS BY7
SPECIFIC ROTATION: -17°- -20°
RELATIVE MATERIAL: MAJORS≤2.5%
OTHERS≤1%
TOTAL IMPURITY≤5.0%
ETHANOL: ≤5.0%
FORMAMIDE: ≤3.0%
RESIDUE ON IGNITION: ≤0.1%
HEAVY METAL: ≤20PPM
WATER: ≤1.0%
ASSAY (HPLC, BASIS ON DRYING): B1a≥90.0%
95.0%≤B1a + B1b≤102.0%
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