- Min.Order :100 Gram
- Purity: 99.6%
- Payment Terms : T/T,
Keywords
riluzole riluzole powder RILUZOLE WITH GMP
Quick Details
- Appearance:White or almost white crystalline powder
- Application:(1) It is dangerous goods. UN 2811 6.1/PG 3 (2) For amyotrophic lateral sclerosis therapy, prolong survival and / or time delayed tracheotomy. (3)CAS No.: 1744-22-5
- PackAge:25kg/drum
- ProductionCapacity:100|Kilogram|Day
- Storage:
- Transportation:by air
Superiority:
1. Usage of Riluzole
(1) It is dangerous goods. UN 2811 6.1/PG 3
(2) For amyotrophic lateral sclerosis therapy, prolong survival and / or time delayed tracheotomy.
2. Sinoway's advantage:
(1) ISO 9001:2008 certificated company
(2) 28 years in pharmaceutical industry
(3)China office of Fischer Chemicals AG (Switzerland)
Details:
Certificate of Analysis of Riluzole
|
Test |
Specification |
Result |
|
Appearance |
White or almost white crystalline powder, odorless |
white crystalline powder, odorless |
|
Solubility |
Conforms |
Conforms |
|
Melting point |
117~119.5℃ |
118.5~119.5℃ |
|
Identification 1):HPLC absorption:
2): IR absorption: |
Max absorption at 254nm±2nm, 282nm±2nm,287nm±2nm
The IR absorption spectrum obtained with the test solution is concordant with that obtained with its reference solution. |
Max absorption at 253.5nm, 280.5n,287.0nm Conforms |
|
Testing Ethanol solution Clarity and color |
Conforms |
Conforms |
|
Related Substances |
Single Impurity : ≤0.5% Total impurity: ≤1.0% |
0.17% 0.19% |
|
Water |
≤0.5% |
0.031% |
|
Sulfated ash |
≤0.1% |
0.05% |
|
Heavy Metals |
≤10ppm |
<10ppm |
|
Microbial Limit Bacteria Mould, yeast Escherichia Coli |
≤1000cfu/g ≤100cfu/g Not detected |
<10cfu/g <10cfu/g Not detected |
|
Assay |
≥98.5%(dried, without water) |
99.6% |
|
Conclusion |
Complies with the Current CP2010 Specification |
|
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