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Safinamide - NDSRI's
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N-Nitroso-Safinamide

  • CAT NUMBER DCTI-C-3711
  • CAS NUMBER 2657645-00-4
  • MOLECULAR FORMULA C17H18FN3O3
  • MOLECULAR WEIGHT 331.35
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References
FAQ's

References

  1. Dostert, Philippe; Pevarello, Paolo; Heidempergher, Franco; Varasi, Mario; Bonsignori, Alberto; Roncucci, Romeo, N-phenylalkyl substituted alfa-amino carboxamide derivatives and process for their preparation, Farmitalia Carlo Erba S.r.l., Italy, EP400495B1, November 3, 1993
  1. Dal Bo, Lorenzo; Mazzucchelli, Paolo; Fibbioli, Monia; Marzo, Antonio, Bioassay of safinamide in biological fluids of humans and various animal species, Arzneimittel Forschung Volume: 56, Issue: 12, Pages: 814-819, 2006

Frequently Asked Questions

Analytical methods, such as high-performance liquid chromatography (HPLC), are commonly used to detect and quantify impurities in Safinamide.  The most effective separation of impurities involved using an Inertsil ODS-3 column with a mobile phase consisting of 0.1% formic acid in water (pH adjusted to 5.0) and acetonitrile in gradient mode.

Yes, impurities in safinamide can impact patient safety. Depending on their nature and concentration, contaminants can cause adverse effects or reduce the efficacy of the medication.

It is essential to synthesize impurities of Safinamide to accurately identify, characterize, and establish their permissible limits within the drug product.

Safinamide impurities should be stored at a controlled room temperature between 2-8 ⁰C or as indicated on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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