1422619-13-3

Basic information

• Product Name: Rosuvastatin IMpurity SodiuM Salt (5-Oxo Rosuvastatin SodiuM Salt)
• Synonyms: Rosuvastatin IMpurity SodiuM Salt (5-Oxo Rosuvastatin SodiuM Salt);(3r,6e)-7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(methyl(methylsulfonyl)amino)-5-pyrimidinyl)-3-hydroxy-5-oxo-6-heptenoic acid;(3R,6E)-7-[4-(4-uorophenyl)-2-[methyl(methylsulfonyl)amino]-6-(propan-2-yl)pyrimidin-5-yl]- 3-hydroxy-5-oxohept-6-enoic acid;Rosuvastatin calcium EP Impurity C;3-Hydroxy-5-keto Rosuvastatin;Rosuvastatin (R700500) impurity;Rosuvastatin EP impurity;Rosuvastatin Impurity C
• CAS NO: 1422619-13-3
• Molecular Formula: C22H26FN3O6S
• Molecular Weight: 479.5217432
• EINECS: 604-604-1
• Mol File: 1422619-13-3.mol
• Article Data: 3

Chemical Properties

• Boiling Point: 731.0±70.0 °C(Predicted)
• Appearance: /
• Density: 1.365±0.06 g/cm3(Predicted)
• PKA: 4.17±0.10(Predicted)
• CAS DataBase Reference: Rosuvastatin IMpurity SodiuM Salt (5-Oxo Rosuvastatin SodiuM Salt)(CAS DataBase Reference)
• NIST Chemistry Reference: Rosuvastatin IMpurity SodiuM Salt (5-Oxo Rosuvastatin SodiuM Salt)(1422619-13-3)
• EPA Substance Registry System: Rosuvastatin IMpurity SodiuM Salt (5-Oxo Rosuvastatin SodiuM Salt)(1422619-13-3)

Safety Data

• Hazardous Substances Data: 1422619-13-3(Hazardous Substances Data)

Usage

Description

Rosuvastatin Impurity Sodium Salt (5-Oxo Rosuvastatin Sodium Salt) is a chemical compound derived from Rosuvastatin, a widely used HMG-CoA reductase inhibitor for the treatment of high cholesterol and related cardiovascular conditions. This impurity is identified as Rosuvastatin EP Impurity C (Calcium Salt) and is used in the pharmaceutical industry for various purposes, including quality control and research.

Uses

Used in Pharmaceutical Industry:
Rosuvastatin Impurity Sodium Salt (5-Oxo Rosuvastatin Sodium Salt) is used as a reference standard for the identification, quality control, and assurance of the purity and potency of Rosuvastatin in the pharmaceutical industry. It helps in the development and validation of analytical methods and ensures the safety and efficacy of the final drug product.
Used in Research and Development:
In the field of research and development, Rosuvastatin Impurity Sodium Salt (5-Oxo Rosuvastatin Sodium Salt) serves as an essential compound for studying the effects of impurities on the pharmacological properties, stability, and safety of Rosuvastatin. This understanding aids in the optimization of the drug formulation and manufacturing processes, ultimately contributing to the overall quality of the medication.

Upstream product

• 355806-00-7 rosuvastatin tert-butyl ester 
• 289042-12-2 2-[(4R,6S)-6-[(E)-2-[4-(4-fluorophenyl)-2-(N-methylmethanesulfonamido)-6-(isopropyl)pyrimidin-5-yl]vinyl]-2,2-dimethyl-1,3-dioxan-4-yl]acetic acid tert butyl ester 
• 124752-23-4 tert-butyl 2-[(4R,6S)-6-formyl-2,2-dimethyl-1,3-dioxan-4-yl]acetate 
• 147118-39-6 methyl (3R,6E)-7-[4-(4-fluorophenyl)-2-(N-methylmethanesulfonamido)-6-(propan-2-yl)pyrimidin-5-yl]-3-hydroxy-5-oxohept-6-enoate 
• 147118-35-2 methyl (3R)-3-(tert-butyldimethylsilyloxy)-5-oxo-6-triphenylphosphoranylidenehexanoate 
• 147118-37-4 N-[4-(4-fluorophenyl)-5-formyl-6-isopropylpyrimidin-2-yl]-N-methylmethanesulfonamide 

Relevant articles and documents

Enrichment of Relevant Oxidative Degradation Products in Pharmaceuticals With Targeted Chemoselective Oxidation

The ability to produce and isolate relatively pure amounts of relevant degradation products is key to several aspects of drug product development: (a) aid in the unambiguous structural identification of such degradation products, fulfilling regulatory requirements to develop safe formulations (International Conference on Harmonization Q3B and M7); (b) pursue as appropriate safety evaluations with such material, such as chronic toxicology or Ames testing; (c) for a specified degradation product in a late-stage regulatory filing, use pure and well-characterized material as the analytical standard. Producing such materials is often a resource- and time-intensive activity, either relying on the isolation of slowly formed degradation products from stressed drug product or by re-purposing the drug substance synthetic route. This problem is exacerbated if the material of interest is an oxidative degradation product, because typical oxidative stressing (H2O2 and radical initiators) tends to produce a myriad of irrelevant species beyond a certain stress threshold, greatly complicating attempts for isolating the relevant degradation product. In this article, we present reagents and methods that may allow the rapid and selective enrichment of active pharmaceutical ingredient with the desired oxidative degradation product, which can then be isolated and used for purposes described above.

Ruishufatatinggan known method for the preparation of impurity

The invention relates to a preparation method of known impurities of rosuvastatin. The preparation method comprises the following step: by taking 4-(4-fluorophenyl)-5-triphenyl phosphine bromine-6-isopropyl-2-[(N-methyl-N-methanesulfonamido)]-pyrimidine as a raw material, preparing (bis-[E-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl) amino]-pyrimidine-yl]-3R-3-hydroxyl-5-oxo-6-heptenoic acid] calcium salt through witting reaction, acidification, oxidization, alkaline hydrolysis and salt forming reaction to obtain the known impurities of rosuvastatin. The preparation method is short in synthetic line and simple to operate, and the product obtained is high in purity and can be applied to research of reference substances.