API
GMP certificate
ITEM |
SPECIFICATIONS |
RESULTS |
IDENTIFICATION |
A, THE INFRARED ABSORPTION SPECTRUM; B, THE THIN-LAYER CHROMATOGRAPHY; C, THE RESIDUE MELTS AT 80°C TO 82°C OR AT 90°C TO 92°C D, THE REACTION OF PRIMARY AROMATIC AMINES. |
CONFORMS |
MELTING POINTS |
ABOUT 198°C, WITH DECOMPOSITION |
197.3~198.4°C |
CHARACTERISTICS |
WHITE OR YELLOWISH-WHITE CRYSTALLINE POWDER OR CRYSTALS |
CONFORMS |
APPEARANCE OF SOLUBITION |
NOT MORE INTENSELY COLORED THAN Y5, BY5 OR GY5 |
<BY5 |
ACIDITY |
NMT 0.2ML |
<0.2ML |
RELATED SUBSTANCES |
NMT 0.5% |
<0.5% |
HEAVY METALS |
NMT 20PPM |
<20PPM |
LOSS ON DRYING |
NMT 0.5% |
0.10% |
SULPHATED ASH |
NMT 0.1% |
0.05% |
ASSAY (ON DRY BASIS ) |
99.0~101.0% |
99.9% |
CONCLUSION: CONFORMS TO THE STANDARD OF BP. |
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