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Cephapirin Benzathine 97468-37-6 C33H37N5O6S2
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Items | Standards | Results | |
Appearance | White to light yellow solid powder | Light yellow solidpowder | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Solubility | Soluble in Dimethylsulfoxide,slightly soluble in Ethanol and Acetonitrile,with pH dependent aqueous solubility | Complies | |
Water Content(KF) | ≤ 1.00% | 0.46% | |
Residue on Ignition | ≤ 0.10% | 0.07% | |
Heavy Metals | ≤ 20ppm | Complies | |
Mesylate | 15.20%~18.20% | 16.80% | |
Residual Solvents | Acetonitrile: ≤410ppm | ND | |
Acetone: ≤5000ppm | 1200ppm | ||
Tetrahydrofuran: ≤720ppm | ND | ||
Related Substances | Maximum single impurity: ≤0.20% | 0.03% | |
Total impurities: ≤1.00% | 0.10% | ||
Assay | 98.00%~102.00% | 99.93% | |
(HPLC basis on drying) | |||
Particle Size | D90: ≤100µm | Complies | |
Reference Standard | In-house Standard | ||
Conclusion | The product complied to In-house standard. |
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Suitable for under 50kg | Suitable for more than 50kg | Suitable for more than 500kg |
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