Fluvastatin EP Impurity B

Improvement of development and validation of an RP-​HPLC method for the fluvastatin sodium using QbD approach and its application to forced degradation studies
By Balasaheb, Dhamdhere Rupali; Vijayalakshmi, A.
From International Journal of Research in Pharmaceutical Sciences (Madurai, India) (2020), 11(4), 6938-6948
 
Method development and validation of Fluvastatin by RP-​HPLC
By Monika, Mallepally; Preethi, Ch. Sai; Aruna Rekha, D.; Pandey, Durgesh; Madhuri, G.
From World Journal of Pharmacy and Pharmaceutical Sciences (2020), 9(5), 1342-1351
 
Development and Validation of Stability-​Indicating HPLC Methods for Quantitative Determination of Pravastatin, Fluvastatin, Atorvastatin, and Rosuvastatin in Pharmaceuticals
By Gomes, Fabio Pereira; Garcia, Pedro Lopez; Alves, Joao Marcel Porto; Singh, Anil Kumar; Kedor-Hackmann, Erika Rosa Maria; Santoro, Maria Ines Rocha Miritello
From Analytical Letters (2009), 42(12), 1784-1804

Fluvastatin EP Impurity B is chemically 1,1-Dimethylethyl (3R,5S,6E)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate (as per EP). It is also known as (3R,5S)-Fluvastatin t-Butyl Ester. Fluvastatin EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Fluvastatin EP Impurity B can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Fluvastatin.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.