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ITEM | SPECIFICATION | TEST RESULT |
APPEARANCE |
WHITE CRYSTALLINE POWDER |
WHITE CRYSTALLINE POWDER |
INFRARED | PASS | PASS |
IDENTIFICATION | PASS | PASS |
ASSAY | 98.0-102.0% | 99.43% |
SPECIFIC ROTATION[α]D | +14.50°~+16.50° | +15.25° |
TRANSMITTANCE | ≥95.0% | 99.6% |
LOSS ON DRYING | ≤4.50% | 2.61% |
RESIDUE ON IGNITION | ≤0.20%º | 0.09% |
HEAVY METALS | ≤10PPM | <10PPM |
PH VALUE | 4.5-6.0 | 5.35 |
LEAD | ≤1PPM | <1PPM |
ARSENIC | ≤3PPM | <3PPM |
OTHER RELATED SUBSTANCES | <2.0% | <2.0% |
RESIDUE SOLVENT |
MEETS THE REQUIREMENTS |
MEETS THE REQUIREMENTS |
5-BENZYL-3.6-DIOXO-2-PIPERAZI NEACETIC ACID | ≤1.5% | <1.5% |
PARTICLE SIZE | ≤1% ON 100MESH | <1% |
TOTAL AEROBIC PLATE COUNT | ≤250CFU/G | 15CFU/G |
TOTAL AEROBIC YEAST AND MOLD COUNT | ≤100CFU/G | <100CFU/G |
PATHOGENS | NEGATIVE | NEGATIVE |