SPECIFICATION
Pharmacopoeia | BP2015/USP38 |
Appearance | A white or almost white crystalline powder |
Appearance of solution | Clear, not more intense than Y7 |
Identification | (1) Should be positive reaction (2) Consistent with the reference IR spectra |
PH | 2.4~3.0 |
Heavy metals | NMT20ppm |
Loss on drying | NMT0.5% |
Sulfated ash | NMT0.1% |
Chloride content | 16.9~17.6% |
Related substances: | |
Impurity B | NMT0.15% |
Unspecified impurities | NMT0.10% |
Total impurities | NMT0.2% |
Residual solvent (Ethanol) | NMT0.3% |
Assay | 99.0% ~ 101.0% |
MOLECULAR STRUCTURE:
Molecular Formula:C8H12ClNO3