65277-42-1 Ketoconazole 1-acetyl-4-(4-{[(2R)-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine
Prouduct name: Ketoconazole
CAS: 65277-42-1
Appearance: White or almost white crystal powder
Purity: 98.5%min
Items | Standard | Results | |||||
Characters | A white or almost white powder. | almost white powder | |||||
Identification | Melting point: 148°C ~ 152°C | 148.0°C ~ 150.0°C | |||||
IR | Qualified | ||||||
TLC | |||||||
gives reaction of chlorides | |||||||
Appearance of solution | Meets the requirements | Qualified | |||||
Optical rotation | -0.10º~ +0.10º | 0° | |||||
Related substances | ≤0.5% | 0.11% | |||||
Heavy metals | ≤0.002% | <0.002% | |||||
Loss on drying | ≤0.5% | 0.08% | |||||
Sulphated ash | ≤0.1% | 0.05% | |||||
Assay | 99.0%~101.0% | 99.06% | |||||
CONCLUSION: | The product complies to the standard of BP2010/EP6.0. |
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