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Analysis Item | Specification | Results |
APPEARANCE | ALMOST WHITE OR LIGHT YELLOW CRYSTALLINE | ALMOST WHITE CRYSTALLINE |
Identification | ||
(a)IR | (a) IR CONFIRMS TO THE CRS(2.2.24) | (a)CONFORM |
(b)TLC | (b) THE PRINCIPAL SPOT IN THE CHROMATOGRAM OBTAINED WITH THE TEST SOLUTION IS SIMILAR IN POSITION AND SIZE TO THE REFERENCE SOLUTION | (b)CONFORM |
(c)LOD | (c) ≤ 0.3% | (c)0.2% |
COLOR AND CLARITY OF SOLUTION | ≤ NO.1 | CONFORM |
≤ Yellow No.1 | ||
EACH IMPURITY | ≤0.5% | 0.10% |
TOTAL IMPURITIES | ≤ 1.0% | 0.20% |
LOSS ON DRYING | ≤ 0.3% | 0.20% |
MELTING POINT | 50-54.0ºC | 51-54ºC |
SULFATED ASH | ≤ 0.2% | 0.06% |
ASSAY(ON THE DRIED BASIS) | ≥ 99.0% | 99.60% |