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Transport Package: | 2-8 Degree |
Specification: | USP/EP |
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Rocuronium is a skeletal muscle relaxant. Clinically, it is mainly used for general anesthesia, skeletal muscle relaxation and endotracheal intubation.
Product name/CAS | Rocuronium Bromide/119302-91-9 | ||
Batch No | 191206 | Batch Qty | 3.28kg |
MFG. Date | 2019.12.06 | Report Date | 2019.12.08 |
Ref. Standard | USP41 | EXP. Date | 2021.12.05 |
Items | Specifications | Results | |
Description | Almost white or pale yellow, slightly pink, slightly hygroscopic crystalline powder | Almost white or pale yellow | |
Solubility | Freely soluble in water and in anhydrous ethanol | Complies | |
Identification | (1)IR Spectrum conforms with RS | Complies | |
(2)gives reaction of bromides | Complies | ||
Appearance of solution | Dissolve 0.10 g in carbon dioxide-free water R and dilute to 10 ml with the same solvent. Solution is clear | Complies | |
Solution is not more intensely colored than reference solution | Complies | ||
pH | 7.0~9.5 | 9.18 | |
Specific optical rotation | + 28.5°~ + 32.0° | +29.6° | |
Related substances | individual known impurities A≤0.2%;(B, C)≤0.3%;(D, E, F, G, H)≤0.1% | A0.02%;C:0.05%; F: 0.08%; D,E,H,B,G: not found(≤0.05%); |
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Individual unknown impurity ≤0.1% | Complies | ||
Total impurities ≤1.5% | <<>0.5%, Complies | ||
Chlorides | ≤0.1% | 0.06% | |
Elemental Impurities | (Cd,Pb,As,Hg,Co,V,Ni,Li,Sb)≤0.5ppm,Cu≤2.5ppm | Complies | |
Water | ≤4.0% | 2.99% | |
Sulphated ash | ≤0.1% | 0.03% | |
Endotoxins | ≤7EU/mg | <<>1EU/mg | |
Assay | 98.0%~102.0% | 99.7% | |
Conclusion | The material complies to specifications given above |
Standard export packing (1.0KG/ Al-foil bag, 25KGS/ drum).
100KGs to 500KGs, within three working days after confirming order
500KGs to 1000KGs, within seven working days.
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