CERTIFICATE OF ANALYSIS
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PRODUCT NAME: Atorvastatin EP Impurity I
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Date of Mfg: Sample COA
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RETEST DATE: Sample COA
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Catalogue Number
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ATV-030
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Lot Number
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Sample COA
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Batch Quantity
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Sample COA
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CAS Number
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125971-95-1
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Mol. Formula
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C40H47FN2O5
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Molecular Wt
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654.8 g/mol
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Long Term Storage Condition
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2-8°C Refrigerator
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Handling instruction
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Sample COA
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IUPAC
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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
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Chemical Name
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Atorvastatin EP Impurity I
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Synonyms
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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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| Test |
Results
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| Appearance |
White Solid
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| Identification by 1H NMR |
Sample COA
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| Identification By IR |
Sample COA
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| Mass (ESI) |
Sample COA
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| Purity |
NLT 98%
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| Wt. Loss by TGA |
Sample COA
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| % Potency |
Sample COA
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| Solubility |
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| QC Release Date |
Sample COA
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| Attachments |
Sample COA
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Note: This material can be used as a referance standard and is for research purpose ONLY and not for human consumption
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This is Sample COA
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