Manufactur standard China Lose Weight Cetilistat - High Purity 50700-72-6 Vecuronium bromide with BP USP EP Quality Standard – Yibai
Manufactur standard China Lose Weight Cetilistat - High Purity 50700-72-6 Vecuronium bromide with BP USP EP Quality Standard – Yibai Detail:
| Product name | Vecuronium bromide |
| Synonyms | (+)-1-(3,17-Diacetoxy-2-piperidino-5-androstan-16-yl)-1-methylpiperidinium bromide |
| CAS No. | 50700-72-6 |
| Appearance | White powder |
| Molecular Formula | C34H57BrN2O4 |
| Molecular Weight | 637.74 |
| Application | Pharma grade or research purpose |
| Packing | As per your request |
| Storage | Preserve in tight,light-resistant containers in a cool place |
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Certificate of Analysis Test according to: BP2013/EP8.0 Vecuronium Bromide (CAS#50700-72-6) |
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ITEMS |
STANDARDS |
RESULTS |
| Appearance | White or almost white crystals or crystalline powder | Complies |
| Solubility | Slightly soluble in water, freely soluble in methylene chloride, sparingly soluble in acetonitrile and in anhydrous ethanol. | Complies |
| Identification | IR: Spectrum exhibits maxima at the same wavelengths as that of the reference standard | Complies |
| Responds to test for Bromides | Complies | |
| Appearance of Solution | The solution is clear and not clear than BY7 | Complies |
| Water | ≦4.0% | 0.88% |
| Specific Rotation | +30.5°to+35.0° | +33.9° |
| Residue on Ignition | ≦0.1% | 0.065% |
| Related Substances | Related Compound D: Not more than 0.25%Related Compound E: Not more than 0.25%
Related Compound C: Not more than 0.25% Related Compound A: Not more than 0.25% Related Compound B: Not more than 0.25% Individual Unknown Impurity: Not more than 0.10% Total impurities: Not more than 0.7% |
Not detectedNot detected
0.052% Not detected Complies 0.045% 0.13% |
| Assay (HPLC) | Between 99.0% w/w to 101.0% w/w on dried basis | 99.86% |
| Bacterial Endotoxins | ≦10EU/mg | 8.8EU/mg |
| Conclusion | It meets BP2013/EP8.0 standards. | |
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Certificate of Analysis Test according to: USP40 Vecuronium Bromide (CAS#50700-72-6) |
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|
ITEMS |
STANDARDS |
RESULTS |
| Appearance | White or almost white crystals or crystalline powder | Complies |
| Solubility | Slightly soluble in water, freely soluble in methylene chloride; sparingly soluble in acetonitrile and in anhydrous ethanol. | Complies |
| Identification | IR: Spectrum exhibits maxima at the same wavelengths as that of the reference standard | Conforms |
| The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation as obtained in the assay. | Conforms | |
| Responds to test for Bromides | Conforms | |
| Loss on Drying | ≦2.5% | 0.96% |
| Specific Rotation | -16°to-20° | -19.6° |
| Residue on Ignition | ≦0.1% | 0.069% |
| Heavy Metals | Not more than 10ppm | <10ppm |
| Related Substances | Pancuronium Bromide: Not more than 0.5%Related Compound F: Not more than 0.5%
Related Compound C: Not more than 0.5% Related Compound A: Not more than 0.3% Related Compound B: Not more than 0.5% Individual Unknown Impurity: Not more than 0.10% Total impurities: Not more than 1.0% |
Complies0.055%
Not detected Not detected Not detected 0.048% 0.16% |
| Assay (HPLC) | Between 98.0% w/w to 102.0% w/w on dried basis | 99.95% |
| Residual Solvents | Methanol≦ 200ppmMethylene Chloride≦ 600ppm
Acetone≦ 500ppm n-Heptane≤5000ppm |
Not Detected89ppm
Not Detected 790ppm |
| Bacterial Endotoxins | ≦10EU/mg | 8.6EU/mg |
| Conclusion | It meets USP40 standards. | |
Company Information
√ Management layer’s full experience in factory and skilled technicians followers; √ Quality is always our top consideration, Strict QC system; √ 11 years experienced exporting sales team; √ Independent R&D lab; √ Two signed long term GMP workshops; √ Rich resources of plenty idle factories for customized project; √ High Efficiency working team with consistent path.
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By Janice from United Arab Emirates - 2018.07.27 12:26
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By Lorraine from Uruguay - 2017.07.07 13:00
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