Customization: | Available |
---|---|
Powder: | Yes |
Customized: | Non-Customized |
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Items | Specifications | Test Results | |
Appearance | White to a class of white powder | Conforms | |
Identification | The sample'S IR spectrum is according with spectrum of Flumazenil. The retention time of the major peak Flumazenil in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation . |
Conforms Conforms |
|
Melting point | 198ºC to 202ºC | 199.6ºC to 200.7ºC | |
Related substances |
Known impurities |
Impurity A: NMT 0.10% Impurity B: NMT 0.2% Impurity C: NMT 1.0% |
Not detected 0.03% 0.02% |
Individual unknown impurity | NMT 0.10% | 0.02% | |
Total impurities | NMT 0.15% | 0.07% | |
Loss on drying | NMT 0.5% | 0.2% | |
Sulphated ash | NMT 0.1% | 0.05% | |
Heavy metals | NMT 20ppm | 5ppm | |
Bacterial endotoxins | NMT 0.56EU/mg | Conforms | |
Assay (On dried substance) |
99.0-101.0% | 99.93% | |
Guarantees the nature time | 36 months | ||
Conclusion | The test comply with the specification of USP32 | ||
Conclusion: the product conforms to the above specifications. |
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