| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| Batch No. | HF170705 | Quantity | 1.5kgs |
| Mfg. Date | Jul. 05, 2017 | Package | As required |
| Rep. Date | Jul. 08, 2017 | Exp. Date | Jul. 04, 2019 |
| Items | Standards | Results | |
| Appearance | White or off-white solid powder, odorless, hygroscopic | Complies | |
| Identification | By IR | Complies | |
| By HPLC | Complies | ||
| Solubility | Freely soluble in chloroform and ethanol, soluble in acetone, sparingly soluble in water | Complies | |
| Specific Rotation | -54°~-60° | -56.0° | |
| pH | 5.0~6.5 | 5.7 | |
| Water Detemination | ≤5.00% | 2.10% | |
| Residue on Ignition | ≤0.10% | 0.06% | |
| Limit of Methyl Benzenesulfonate | ≤10ppm | ND | |
| Residual Solvents | Acetonitrile: ≤410ppm | ND | |
| Dichloromethane: ≤600ppm | ND | ||
| Ethyl Ether: ≤5000ppm | 400ppm | ||
| Toluene: ≤890ppm | 50ppm | ||
| Related Substances | Cis-Quaternary acid: ≤0.20% | ND | |
| (R)-N-Methyllaudanosine: ≤0.20% | 0.14% | ||
| (R)-Laudanosine: ≤0.60% | 0.18% | ||
| Cis-Quaternary methyl ester: ≤0.40% | ND | ||
| Cis-Quaternary alcohol: ≤0.50% | 0.16% | ||
| R-trans-R-trans-Atracurium: ≤0.20% | ND | ||
| R-cis-R-trans-Atracurium: ≤0.80% | 0.23% | ||
| Trans-Monoquaternary compound: ≤0.50% | ND | ||
| Trans-Monoacrylate: ≤0.50% | ND | ||
| Cis-Monoquaternary compound: ≤0.70% | ND | ||
| Cis-cis-Triester Analog: ≤0.40% | ND | ||
| Cis-Monoacrylate: ≤1.00% | 0.48% | ||
| Any individual unspecified impurity: ≤0.10% | Complies | ||
| Total impurities: ≤3.00% | 1.00% | ||
| Assay (HPLC basis on drying) |
97.0%~102.0% | 99.18% | |
| Reference Standard | USP39 Standard | ||
| Conclusion | The product complied to USP39 standard. | ||
| Storage | Preserve in tight,light-resistant containers in a cool place,desiccated |
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