Pharm-Rx Atorvastatin Calcium

Identification & Functionality

Chemical Name

Atorvastatin Calcium

Molecular formula

C₆₆H₆₈CaF₂N₄O₁₀

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Pharmaceutical Actives & Precursors

Active Pharmaceutical Ingredients (APIs)

Chemical Structure

Definition

Atorvastatin Calcium contains NLT 98.0% and NMT 102.0% of atorvastatin calcium (C₆₆H₆₈CaF₂N₄O₁₀), calculated on the anhydrous and solvent-free basis. If labeled as a propylene glycol solvate, it contains NLT 98.0% and NMT 102.0% of atorvastatin calcium (C₆₆H₆₈CaF₂N₄O₁₀), calculated on the anhydrous, propylene glycol-free, and solvent-free basis. It may contain a suitable antioxidant.

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Other Drug & Care Solutions

Properties

Typical Properties

	Value	Units	Test Method / Conditions
Molecular Weight	1155.36	-	-

Regulatory & Compliance

USP Reference Standards

USP Atorvastatin Calcium RS
USP Atorvastatin Related Compound A RS Calcium (3R,5R)-7-[2-isopropyl-4,5-diphenyl-3-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2);
Also known as Desfluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-2-isopropyl-4,5-diphenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoicacid, calcium salt.

C₆₆H₇₀CaN₄O₁₀ 1119.38
USP Atorvastatin Related Compound B RS Calcium (3S,5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); also known as 3S,5R
Isomer, or (3S,5R)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
C₆₆H₆₈CaF₂N₄O₁₀ 1155.34
USP Atorvastatin Related Compound C RS Calcium (3R,5R)-7-[2,3-Bis(4-fluorophenyl)-5-isopropyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); Also known as Difluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-4,5-bis(4-fluorophenyl)-2-isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
C₆₆H₆₆CaF₄N₄O₁₀  1191.34
USP Atorvastatin Related Compound D RS 3-(4-Fluorobenzoyl)-2-isobutyryl-N,3-diphenyloxirane-2-carboxamide; Also known as Epoxide impurity, or 3-(4-fluorobenzoyl)-2-isobutyryl-3-phenyl-oxirane-2-carboxylic acid phenylamide.
C₂₆H₂₂FNO₄  431.46

USP Atorvastatin Related Compound E RSCalcium (3S,5S)-7-[2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); Also known as 3S,5S Enantiomer, or (3S,5S)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
C₆₆H₆₈CaF₂N₄O₁₀ 1155.36
▲USP Atorvastatin Related Compound H RS Also known as Lactone impurity;▲ (ERR 1-Jun-2023)5-(4-Fluorophenyl)-1-{2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl}-2-isopropyl-N,4-diphenyl-1H-pyrrole-3-carboxamide.
C₃₃H₃₃FN₂O₄ 540.64

▲USP Atorvastatin Related Compound I RS Also known as Acetonide impurity;▲ (ERR 1-Jun-2023)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.
C₄₀H₄₇FN₂O₅  654.82

Storage & Handling

Storage Information

• Preserve the trihydrate form in well-closed containers, and store at room temperature.
• If labeled as amorphous or semicrystalline or as a propylene glycol solvate, store as per labeling instructions.

Possible packaging and storage conditions could include the following: Preserve in well-closed containers protected from light and moisture, or in tight containers; store at room temperature, at controlled room temperature, or at 2 °C - 8 °C; store under nitrogen atmosphere or packed with an oxygen absorber; and store under nitrogen atmosphere, packed with silica gel and an oxygen absorber.