| Customization: | Available |
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| CAS No.: | 50847-11-5 |
| Formula: | / |
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| Product Name | Ibudilast |
| CAS No | 50847-11-5 |
| Appearance | White powder |
| Specification | 99% |
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.
| Item | Specification | Result | Method | ||
| Description | |||||
| Appearance | White powder | Complies | Visual | ||
| Odor | Characteristic | Complies | Organoleptic | ||
| Taste | Characteristic | Complies | Organoleptic | ||
| Part Used | Leaf | Complies | |||
| Particle Size | 100% through 80 mesh | Complies | CP2015 | ||
| Bulk Density | 0.20g/ml~0.40g/ml | 0.25g/ml | CP2015 | ||
| Maker Compounds | |||||
| Chemical Test | |||||
| Loss on drying | ≤5.00% | 3.8% | GB 5009.3 |
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| Heavy Metals | |||||
| Total Heavy Metals | ≤10ppm | Conforms | GB 5009.74 | ||
| Arseni | ≤0.5ppm | Conforms | GB 5009.11 | ||
| Lead | ≤0.5ppm | Conforms | GB 5009.12 | ||
| Mercur | ≤0.1ppm | Conforms | GB 5009.3 | ||
| Microbiological Tests | |||||
| TotalPlate Count | ≤1000cfu/g | 110cfu/g | CP2015 | ||
| Yeast&Mold | ≤100cfu/g | 20cfu/g | CP2015 | ||
| Staphylococcus | Negative | Negative | CP2015 | ||
| Salmonella | Negative | Negative | CP2015 | ||
| E. Coli | Negative | Negative | CP2015 | ||
| storage | Store in cool and dry place,keep away from strong light heat. | ||||
| Genetic Modification State | The product is GMO free products. | ||||
| Free Radiation effect | The product is not been irradiated. | ||||
| Conclusion: | Conform | ||||
| Tested by: | Mr. Yang Fangchao | Approved by: | Mr. Niu Jicheng | ||
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