Customization: | Available |
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Certification: | GMP, FDA, ISO |
Grade Standard: | Medicine Grade |
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Audited by an independent third-party inspection agency
Items | Standards | Results |
Appearance | White to off-white crystalline powder | Complies |
Identification | IR spectrum must comply with working standard spectrum | Complies |
Water solution must display identification of bromide test | Complies | |
Solubility | Easy soluble in Water and Methanol, soluble in Ethanol, slightly soluble in Acetonitrile, almost insoluble in Chloroform | Complies |
Appearance of Solution | Must be complies | Complies |
The Acidity and Alkalinity | Must be complies | Complies |
Loss on Drying | ≤ 0.50% | 0.07% |
Residue on Ignition | ≤ 0.10% | 0.08% |
Heavy Metals | ≤ 10ppm | Complies |
P3-G | ≤ 0.20% | ND |
Residual Solvents | Methanol: ≤3000ppm | ND |
Butanore: ≤5000ppm | 900ppm | |
Ethyl acetate: ≤5000ppm | ND | |
Toluene: ≤890ppm | ND | |
Related Substances | Impurity PID-A: ≤0.10% | ND |
Impurity D-I: ≤0.10% | ND | |
Impurity P3-F: ≤0.10% | ND | |
Impurity E: ≤0.10% | ND | |
The Maximum unknown impurity: ≤0.10% | 0.046% | |
Total impurities: ≤0.50% | 0.08% | |
Assay(on dried basis) | 99.0%~101.0% | 99.85% |
Reference Standard | EP7.1 Standard | |
Conclusion | The product complied to EP7.1 standard. | |
Storage | Preserve in tight,light-resistant containers in a cool place |