| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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Ibudilast is an anti-inflammatory and neuroprotective oral agent which shows an excellent safety profile at 60 mg/day and provides significantly prolonged time-to-first relapse and attenuated brain volume shrinkage in patients with relapsing-remitting (RR) and/or secondary progressive (SP) multiple sclerosis (MS).
Ibudilast is a potential oral treatment for all forms of multiple sclerosis (MS) and for other neurodegenerative disorders, such as amyotrophic lateral sclerosis (ALS). The drug, currently in clinical testing for these diseases, has been marketed in Japan and Korea to treat post-stroke complications and bronchial asthma for over two decades.
Ibudilas use in relapsing-remitting multiple sclerosis (RRMS). In 2016, the drug received Fast Track designation from the U.S. Food and Drug Administration (FDA) to help speed its development as an MS treatment.
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Items
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Specifications
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Results
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Appearance
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White powder |
Confirm
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Odor& Taste
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Characteristic
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Confirm
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Loss on drying
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≤8.0%
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2.8%
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Assay(HPLC)
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98%
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98.2%
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Ash
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≤1.0%
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0.35%
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Heavy Metal
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≤10 ppm
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Confirm
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As
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≤1.0ppm
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Confirm
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Pb
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≤1.0ppm
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Confirm
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Cd
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≤1.0ppm
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Confirm
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Hg
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≤0.1ppm
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Confirm
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Total plate count
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≤1000 cfu/g
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Confirms
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Yeast&Mold
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≤100 cfu/g
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Confirms
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E.Coli
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Negative
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Negative
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Salmonella
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Negative
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Negative
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Staphylococcus aureus
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Negative
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Negative
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