Atorvastatin impurity C

Atorvastatin impurity C - Names and Identifiers

Name	Difluoro Atorvastatin Calcium Salt
Synonyms	Atorvastatin impurity C Atorvastatin EP IMpurity C Atorvastatin Related CoMpound C Atorvastatin Related Compound C Difluoro Atorvastatin SodiuM Salt Difluoro Atorvastatin Calcium Salt Difluoro Atorvastatin CalciuM Salt 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 Atorvastatin Related Compound C (20 mg) (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)
CAS	693793-53-2

Atorvastatin impurity C - Physico-chemical Properties

Molecular Formula	C66H68CaF2N4O10
Molar Mass	1155.3417264
Melting Point	>141°C (dec.)
Solubility	DMSO (Slightly, Heated, Sonicated), Methanol (Slightly)
Appearance	neat
Color	White to Off-White
Storage Condition	Hygroscopic, -20°C Freezer, Under inert atmosphere
Stability	Hygroscopic
Use	Inspection

Atorvastatin impurity C - Risk and Safety

HS Code

2933997500

Atorvastatin impurity C - Introduction

Atorvastatin Calcium impurity III (Difluoro Atorvastatin Calcium Salt) is an important impurity of Atorvastatin Calcium, and its chemical structure has two fluorine atoms substituted for a certain position of Atorvastatin molecule. The following is a description of the properties, uses, preparation and safety information of Atorvastatin Calcium Impurity III:

Nature:
Atorvastatin Calcium Impurity III is a solid compound in the form of a white to off-white crystalline powder. It is stable at room temperature and can be dissolved in water, but its solubility is lower than that of atorvastatin calcium.

Use:
Atorvastatin Calcium Impurity III is generally present as an impurity of the atorvastatin drug substance. Its presence may have an impact on the purity and stability of the drug, so its presence needs to be strictly controlled during the pharmaceutical process. In addition, atorvastatin calcium impurity III is also commonly used to study and monitor the quality of atorvastatin drugs.

Preparation Method:
The preparation method of atorvastatin calcium impurity III can be carried out by chemical synthesis. The specific synthetic steps and conditions may vary depending on the research or pharmaceutical needs.

Safety Information:
There is limited information on the safety of atorvastatin calcium impurity III because most of the research and literature focuses on atorvastatin itself. However, based on the general safety profile of atorvastatin, relatively low toxicity of its impurities can be expected. However, in the pharmaceutical process, its presence needs to be closely monitored to ensure the quality and safety of the product.

Last Update：2024-04-09 21:54:55