Impurity reference standards

Safinamide impurity standards

This page brings together 15 Safinamide related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 1 nitrosamine and 2 metabolites or hydroxylated analogues.

15reference materials

1nitrosamines

2metabolites

Parent API

Safinamide

CAS: 133865-89-1
Formula: C₁₇H₁₉FN₂O₂
MW: 302.34 g/mol
Code: ZX-006801

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Nitrosamines1N-nitroso impurities for ICH M7 work

Metabolites2Hydroxy, desmethyl and conjugated forms

Counts are based on product names. One compound can fall into more than one type.

All Safinamide reference materials

1–15 of 15 standards

(4-((3-Fluorobenzyl)oxy)phenyl)methanol

CAS: 690969-16-5
Formula: C₁₄H₁₃FO₂
MW: 232.25 g/mol

ZX-022726

(R)-Safinamide

CAS: 174756-44-6
Formula: C₁₇H₁₉FN₂O₂
MW: 302.34 g/mol

ZX-026875

(S)-2-((4-Hydroxybenzyl)amino)propanamide

CAS: 1843368-38-6
Formula: C₁₀H₁₄N₂O₂
MW: 194.23 g/mol

ZX-026876

(S)-2-[[3-(3-Fluorobenzyl)-4-[(3-fluorobenzyl)oxy]benzyl]amino]propanamide

CAS: 1000370-27-3
Formula: C₂₄H₂₄F₂N₂O₂
MW: 410.5 g/mol

ZX-026874

(S)-2-[4-(3-Fluorobenzyloxy) benzylamino]propionic acid methyl ester

CAS: 1827614-91-4
Formula: C₁₈H₂₀FNO₃
MW: 317.4 g/mol

ZX-022729

(S)-N-(1-Amino-1-oxopropan-2-yl)-4-((3-fluorobenzyl)oxy)benzamide

CAS: 2268802-59-9
Formula: C₁₇H₁₇FN₂O₃
MW: 316.33 g/mol

ZX-026877

3-(3-Fluorobenzyl)-4-[(3-fluorobenzyl)oxy]benzaldehyde

CAS: 1000370-24-0
Formula: C₂₁H₁₆F₂O₂
MW: 338.3 g/mol

ZX-026878

4- Fluoro Safinamide

CAS: 202825-43-2
Formula: C₁₇H₁₉FN₂O₂
MW: 302.34 g/mol

ZX-022730

4-(3-Fluoro-benzyloxy)-benzaldehyde

CAS: 66742-57-2
Formula: C₁₄H₁₁FO₂
MW: 230.23 g/mol

ZX-022728

N-Nitroso Safinamide

CAS: 2657645-00-4
Formula: C₁₇H₁₈FN₃O₃
MW: 331.34 g/mol

ZX-020391

Ralfinamide

CAS: 133865-88-0
Formula: C₁₇H₁₉FN₂O₂
MW: 302.34 g/mol

ZX-026630

Safinamide

CAS: 133865-89-1
Formula: C₁₇H₁₉FN₂O₂
MW: 302.34 g/mol

ZX-006801

Safinamide Acid

CAS: 1160513-60-9
Formula: C₁₇H₁₈FNO₃
MW: 303.33 g/mol

ZX-020390

Safinamide Metabolite NW 1689

CAS: 405-85-6
Formula: C₁₄H₁₁FO₃
MW: 246.23 g/mol

ZX-022727

Safinamide Methanesulfonate

CAS: 202825-46-5
Formula: C₁₈H₂₃FN₂O₅S
MW: 398.5 g/mol

ZX-026873

Questions

Safinamide impurities, answered

What Safinamide reference materials are available?

The catalogue currently lists 15 compounds for Safinamide, including 1 nitrosamine and 2 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.

What documents come with a Safinamide impurity standard?

A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.

Can Zemixal make a Safinamide impurity that is not listed?

Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.

Do you supply Safinamide nitrosamine impurities?

Yes. 1 N-nitroso compound is listed for Safinamide. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.