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Atorvastatin EP Impurity I

Atorvastatin EP Impurity I
Catalogue number ATV-030
Product Name Atorvastatin EP Impurity I
Sub Category Pharma Reference Standard; Pharmaceutical/API Drug Impurities/Metabolites
API Atorvastatin
CAS Number 125971-95-1
HS Code 29339900
Molecular formula C40H47FN2O5
Molecular Weight 654.8 g/mol
Synonyms Atorvastatin Calcium Impurity I (As per 35.1 EP Monograph); 1,1-Dimethylethyl 2-[(4R,6R)-6-[2-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxan-4-yl]acetate; Atorvastatin Acetonide tert-Butyl Ester; (4R,6R)-6-[2-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-acetic Acid 1,1-Dimethylethyl Ester; Atorvastatin Ketal Impurity; Atorvastatin Acetonide impurity; tert-Butyl 2-((4R,6R)-6-{2-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl)acetate; Atorvastatin Related Compound I (USP)
Chemical Name tert-butyl [(4R,6R)-6-[2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxan-4-yl]acetate
Appearance White Solid
Storage 2-8°C Refrigerator
Applications The product can be used as reference standard.
Information Atorvastatin EP Impurity I is supplied with detailed characterization data compliant with regulatory guideline. Atorvastatin EP Impurity I 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 Atorvastatin.
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Chemical Name: Atorvastatin EP Impurity I

Synonym: Atorvastatin Calcium Impurity I (As per 35.1 EP Monograph); 1,1-Dimethylethyl 2-[(4R,6R)-6-[2-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxan-4-yl]acetate; Atorvastatin Acetonide tert-Butyl Ester; (4R,6R)-6-[2-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-acetic Acid 1,1-Dimethylethyl Ester; Atorvastatin Ketal Impurity; Atorvastatin Acetonide impurity; tert-Butyl 2-((4R,6R)-6-{2-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl)acetate; Atorvastatin Related Compound I (USP)

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