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PHR2379

Supelco

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;

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About This Item

Empirical Formula (Hill Notation):
C17H19FN2O2 · xCH4O3S
CAS Number:
202825-46-5
Molecular Weight:
302.34 (free base basis)
MDL number:
MFCD15145475
UNSPSC Code:
41116107
NACRES:
NA.24

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

application(s)

pharmaceutical small molecule

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)

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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.

Pictograms

Health hazardExclamation mark
GHS08,GHS07

Signal Word

Warning

Hazard Statements

H302,H319,H361d

Hazard Classifications

Acute Tox. 4 Oral - Eye Irrit. 2 - Repr. 2

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAD6709
LRAC4350

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Articles

Safinamide Impurity Profiling by HPLC Assay Methods

HPLC-DAD method on Ascentis® Express C8 column analyzes safinamide purity and related impurities meeting system suitability criteria.

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