PHR2379

Safinamide Mesylate

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Safinamide mesylate salt, (S)-(+)-2-[[4-(3-Fluorobenzoxy)benzyl]amino]propanamide; (S)-2-[[4-[(3-Fluorobenzyl)oxy]benzyl]amino]propanamide; FCE-26743; PNU-151774E, NW-1015;
• Empirical Formula (Hill Notation): C₁₇H₁₉FN₂O₂ · xCH₄O₃S
• CAS Number: 202825-46-5
• Molecular Weight: 302.34 (free base basis)
• MDL number: MFCD15145475
• UNSPSC Code: 41116107

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• API family: safinamide
• form: powder
• CofA: current certificate can be downloaded
• packaging: pkg of 50 mg
• storage temp.: 2-8°C
• SMILES string: CS(O)(=O)=O.C[C@H](NCc1ccc(OCc2cccc(F)c2)cc1)C(N)=O
• InChI: 1S/C17H19FN2O2.CH4O3S/c1-12(17(19)21)20-10-13-5-7-16(8-6-13)22-11-14-3-2-4-15(18)9-14;1-5(2,3)4/h2-9,12,20H,10-11H2,1H3,(H2,19,21);1H3,(H,2,3,4)/t12-;/m0./s1
• InChI key: YKOCHIUQOBQIAC-YDALLXLXSA-N
• Gene Information: human ... MAOB(4129)

Description

General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

Safinamide is a highly selective and reversible monoamine oxidase type B (MAO-B) inhibitor that increases neostriatal dopamine concentration. In addition, safinamide is voltage-dependent sodium and calcium channel blocker. It appears to bind to the batrachotoxin-sensitive site 2 of the voltage-sensitive sodium channels. Safinamide blocks N and L-type calcium channels and inhibits glutamate and aspartate release from synaptic terminals.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC4350 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• pictograms: GHS07,GHS08
• signalword: Warning
• hcodes: H302 - H319 - H361d
• pcodes: P202 - P264 - P270 - P301 + P312 - P305 + P351 + P338 - P308 + P313
• Hazard Classifications: Acute Tox. 4 Oral - Eye Irrit. 2 - Repr. 2
• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable