
Ibutilide Fumarate Acute Cardioconversion And Atrial Flutter Antiarrhythmic Agent
Contact Person : Jimmy Tian
Phone Number : 86-18602905046
WhatsApp : +8618602905046
Minimum Order Quantity : | 15.0g | Price : | to be negotiated |
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Packaging Details : | 1kg in alluminum bag | Delivery Time : | 10 days |
Payment Terms : | T/T, L/C | Supply Ability : | 50 kg per year |
Place of Origin: | China | Brand Name: | LIBANG |
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Certification: | US FDA Approval |
Detail Information |
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Quality Specification: | USP | Colour: | White Or Almost White Powder |
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CAS No: | 3223-07-2 | Certification: | US-FDA |
Pack: | Alum Foil Bag/Carton/Drum | Stock: | 1kg In Stock |
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Product Description
Melphalan Hydrochloride
Melphalan | USP39 | |||||||||||||||||||
BATCH NUMBER | C073-170615 | TEST DATE | 2017/06/15 | |||||||||||||||||
BATCH SIZE | 150g | MANUFACTURING DATE | 2017/06/15 | |||||||||||||||||
QUANTITY | 50G | RETEST DATE | 2020/06/14 | |||||||||||||||||
TEST | SPECIFICATION | RESULT | ||||||||||||||||||
Appearance | A white or off-white powder, crystalline powder | Conform | ||||||||||||||||||
Identification | Identification A UV | UV spectrum corresponds to the UV spectrum of the reference standard | Conform | |||||||||||||||||
Identification B | It gives reaction(a)of chlorides | Conform | ||||||||||||||||||
Specific rotation | -30 and -36 | -31.23 | ||||||||||||||||||
Loss on drying | NMT 7.0% | 3.93% | ||||||||||||||||||
Residue on ignition | NMT 0.3% | 0.04% | ||||||||||||||||||
Ionizable Chlorine | Not more than 1.0 ml of 0.1 N silver nitrate per 500 mg sample | 0.32 ml | ||||||||||||||||||
Nitrogen content | 8.90%-9.45%(on the dried basis) | 9.12% | ||||||||||||||||||
Related compounds |
Impurity D NMT3.0%
|
2.4% | ||||||||||||||||||
Impurity D NMT1.0%
|
0.67% | |||||||||||||||||||
Impurity D NMT0.5%
|
0.13% | |||||||||||||||||||
Impurity D NMT0.5%
|
0.10% | |||||||||||||||||||
Impurity D NMT0.3%
|
0.01% | |||||||||||||||||||
Impurity D NMT0.2%
|
0.04% | |||||||||||||||||||
Unspecified Impurities: NMT0.1% | 0.06% | |||||||||||||||||||
Total impurity: NMT 5.5% NMT 1.0% |
3.61% | |||||||||||||||||||
Residual solvents | Methanol | NMT 3000ppm | conform | |||||||||||||||||
Assay |
93.0 %~100.5% (calculated on the dried and ionizable chlorine-free basis) |
98.56% | ||||||||||||||||||
Packing and Storage: Preserve in tight, light-resistant containers. | ||||||||||||||||||||
Conclusion: | All analythcal methods and results conform to the requirement of USP39 | |||||||||||||||||||
Analysis | 孟庆华 | Checker | 张艳 | Supervisor | 孟庆华 |
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