High Purity 99% CAS: 202825-46-5 Safinamide for Parkinson′s Disease

Model NO.: YJ-Pharm2959
Trademark: YJ-Pharm
Transport Package: Cartoon
Specification: 1kg/foil bag
Origin: China
HS Code: 3001
Model NO.: YJ-Pharm2959
Trademark: YJ-Pharm
Transport Package: Cartoon
Specification: 1kg/foil bag
Origin: China
HS Code: 3001
STORAGE CONDITION: THE PRODUCT SHOULD BE SEALED AND STORED IN COOL AND DRY PLACE
Product Name:
Safinamide mesylate

Synonyms:		 2-amino-resorcinohydrochloride;3-benzenediol,2-amino-hydrochloride
CAS: 202825-46-5
MF: C17H19FN2O2.CH4O3S
MW: 398.449
EINECS: N/A
Product Categories: Pharmaceutical Raw Materials ; Pyrimidine series ; API intermediates ; Nucleotides and Nucleosides ; Antivirals for Research and Experimental Use ; Biochemistry ; Chemical Reagents for Pharmacology Research ; Nucleosides and their analogs ; Nucleosides, Nucleotides & Related Reagents ; Bases & Related Reagents ; Nucleotides



Salbactamide has a dual mechanism of action, in addition to inhibit MAO-B, but also has the additional function of inhibiting glutamate release (glutamate release), in theory, this may have neuroprotective effect, compared to the current only provide symptomatic treatment , Safinamide is more able to meet the key unmet need in the market and the current MAO-B inhibitors, especially Azilect, have also been proposed to have neuroprotective effects, but the clinical data do not fully support this hypothesis. Therefore, safenamide is likely to become more favored by doctors of drugs. In any case, doctors have great hopes for this medicine and believe it can slow the progress of the disease.

Certificate  of  Analysis
Product Name: Safinamide Mesylate
CAS No.: 202825-46-5
 
Batch No. HF171108 Quantity 5.8kgs
Mfg. Date Nov. 08, 2017 Package As required
Rep. Date Nov. 11, 2017 Exp. Date Nov. 07, 2019
Items Standards Results
Appearance White or off-white solid powder Complies
Identification By IR Complies
By HPLC Complies
Solubility Very soluble in methanol and water, soluble in ethanol, slightly soluble in isopropanol, insoluble in ethyl acetate and n-hexane Complies
Polymorphic Form Consistent with the original patent reference Complies
Melting Point 214ºC~218ºC 216ºC~217ºC
Specific Rotation +10.5°~+15.5° +11.3°
Loss on Drying ≤ 1.00% 0.10%
Heavy Metals ≤ 20ppm Complies
Residue on Ignition ≤ 0.10% 0.03%
Ethyl Methanesulfonate ≤ 25ppm ND
Chiral Isomer ≤ 0.50% ND
Residual Solvents Methanol: ≤3000ppm 1100ppm
Methylbenzene: ≤890ppm 100ppm
Ethanol: ≤5000ppm 700ppm
Ethyl Acetate: ≤5000ppm 1200ppm
Benzene: ≤2ppm ND
Related Substances Impurity G: ≤0.03% ND
Any single impurity: ≤0.10% 0.05%
Total Impurities: ≤1.00% 0.07%
Assay                  (on the anhydrous basis) 98.0%~102.0% 99.85%
Particle Size D90: ≤100µm Complies
Reference Standard In-house Standard
Conclusion The product complied to In-house standard.
Storage Preserve in tight,light-resistant containers in a cool place

  STORAGE CONDITION: THE PRODUCT SHOULD BE SEALED AND STORED IN COOL AND DRY PLACE
Product Name:
Safinamide mesylate

Synonyms:		 2-amino-resorcinohydrochloride;3-benzenediol,2-amino-hydrochloride
CAS: 202825-46-5
MF: C17H19FN2O2.CH4O3S
MW: 398.449
EINECS: N/A
Product Categories: Pharmaceutical Raw Materials ; Pyrimidine series ; API intermediates ; Nucleotides and Nucleosides ; Antivirals for Research and Experimental Use ; Biochemistry ; Chemical Reagents for Pharmacology Research ; Nucleosides and their analogs ; Nucleosides, Nucleotides & Related Reagents ; Bases & Related Reagents ; Nucleotides



Salbactamide has a dual mechanism of action, in addition to inhibit MAO-B, but also has the additional function of inhibiting glutamate release (glutamate release), in theory, this may have neuroprotective effect, compared to the current only provide symptomatic treatment , Safinamide is more able to meet the key unmet need in the market and the current MAO-B inhibitors, especially Azilect, have also been proposed to have neuroprotective effects, but the clinical data do not fully support this hypothesis. Therefore, safenamide is likely to become more favored by doctors of drugs. In any case, doctors have great hopes for this medicine and believe it can slow the progress of the disease.

Certificate  of  Analysis
Product Name: Safinamide Mesylate
CAS No.: 202825-46-5
 
Batch No. HF171108 Quantity 5.8kgs
Mfg. Date Nov. 08, 2017 Package As required
Rep. Date Nov. 11, 2017 Exp. Date Nov. 07, 2019
Items Standards Results
Appearance White or off-white solid powder Complies
Identification By IR Complies
By HPLC Complies
Solubility Very soluble in methanol and water, soluble in ethanol, slightly soluble in isopropanol, insoluble in ethyl acetate and n-hexane Complies
Polymorphic Form Consistent with the original patent reference Complies
Melting Point 214ºC~218ºC 216ºC~217ºC
Specific Rotation +10.5°~+15.5° +11.3°
Loss on Drying ≤ 1.00% 0.10%
Heavy Metals ≤ 20ppm Complies
Residue on Ignition ≤ 0.10% 0.03%
Ethyl Methanesulfonate ≤ 25ppm ND
Chiral Isomer ≤ 0.50% ND
Residual Solvents Methanol: ≤3000ppm 1100ppm
Methylbenzene: ≤890ppm 100ppm
Ethanol: ≤5000ppm 700ppm
Ethyl Acetate: ≤5000ppm 1200ppm
Benzene: ≤2ppm ND
Related Substances Impurity G: ≤0.03% ND
Any single impurity: ≤0.10% 0.05%
Total Impurities: ≤1.00% 0.07%
Assay                  (on the anhydrous basis) 98.0%~102.0% 99.85%
Particle Size D90: ≤100µm Complies
Reference Standard In-house Standard
Conclusion The product complied to In-house standard.
Storage Preserve in tight,light-resistant containers in a cool place

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