ATORVASTATIN CALCIUM

PRODUCT IDENTIFICATION

CAS NO. 134523-03-8

ATORVASTATIN CALCIUM

EINECS NO.  
FORMULA (C33H34FN2O5)2Ca·3H2O
MOL WT. 1209.42

H.S. CODE

 

TOXICITY

 
DERIVATION

 

SYNONYMS Lipitor;
(-)-Monocalcium bis[(3R, 5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl- 4-phenylcarbamoyl-1H- pyrrol-1-yl]-3,5-dihydroxyheptanoate] Trihydrate; [R-(R',R')]-2-(4-fluorophenyl)-beta,delta- dihydroxy-5-( 1-methylethyl)-3-phenyl-4 [(phenylamino) carbonyl]- lH-pyrrole-1-heptanoic acid, calcium salt (2:1) Trihydrate;

CLASSIFICATION

 

PHYSICAL AND CHEMICAL PROPERTIES

PHYSICAL STATE
white to off-white crystalline powder
MELTING POINT  
BOILING POINT

 

SPECIFIC GRAVITY  
SOLUBILITY IN WATER Slightly soluble
pH  
VAPOR DENSITY

 

AUTOIGNITION

 

NFPA RATINGS

 

REFRACTIVE INDEX

 

FLASH POINT

 

STABILITY

Stable under ordinary conditions.

GENERAL DESCRIPTION & APPLICATIONS

Atorvastatin, a synthetic cholesterol-lowering agent, is a medicine called HMG-CoA (3 hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitor. This enzyme is involved in cholesterol biosynthesis by catalyzing the conversion reaction of HMG-CoA to mevalonate. The fuction of lowering the amount of cholesterol leads to the result in clearing the LDP (low-density lipoprotein) cholesterol in the blood by increased LDL receptors. The calcium salt of atorvastatin is used in the treatment of primary hypercholesterolema and dyslipidemia. It is a white to off-white crystalline powder; slightly soluble in water (insoluble in aqueous solutions of pH 4 or below); soluble in methanol, dimethyl sulfoxide; administered orally. The chemical designation is [R-(R',R')]-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-( 1-methylethyl)-3-phenyl-4 [(phenylamino) carbonyl]- lH-pyrrole-1-heptanoic acid, calcium salt (2:1).

HMG-CoA reductase inhibitors (commonly called "statins") can be classified in two groups.

  • Semi-Synthetic
    • Lovastatin ( CAS RN: 75330-75-5)
    • Simvastatin ( CAS RN: 79902-63-9)
    • Pravastatin Sodium ( CAS RN: 81131-70-6)
  • Synthetic
    • Fluvastatin Sodium ( CAS RN: 93957-55-2)
    • Atorvastatin Calcium ( CAS RN: 134523-03-8)
    • Cerivastatin Sodium ( CAS RN: 143201-11-0)
    • Rosuvastatin Calcium ( CAS RN: 147098-20-2)
SALES SPECIFICATION

APPEARANCE

white to off-white crystalline powder

IDENTIFICATION

Complies (Test A,B)

ASSAY

98.0% - 101.0%

CALCIUM

3.3% - 3.6%

WATER

7.0% max

LOSS ON DRYING

0.5% max

TRANSPORTATION
PACKING
 
HAZARD CLASS  
UN NO.  
OTHER INFORMATION
Hazard Symbols: , Risk Phrases: , Safety Phrases: 22-24/25

GENERAL DESCRIPTION OF CHOLESTEROL

Cholesterol is a steroid alcohol that is essentially insoluble in aqueous solutions. In mammals it is normally solubilized by its association with other lipids, such as phospholipids or bile acids; thus, most cholesterol is found in cell membranes, plasma lipoproteins, and bile. Cholesterol can be esterified with a fatty acid to form cholesteryl esters. The latter form discrete lipid droplets in cells, especially in cells of steroidogenic tissues, and in the lipid core of low-density lipoproteins in the blood. Cholesterol is a fatty lipid sparingly insoluble in water but soluble in a number of organic solvents. It is the most common sterol of eukaryotes which a key constituent of cell membranes and works as the precursor of bile acids, cholecalciferol (vitamin D)  and steroid hormones including cortisol, cortisone, aldosterone and sex hormone progesterone in vertebrates. Cholesterol is used as an emulsifying agent in pharmaceuticals. The most cholesterols are synthesized by the liver and other tissues include the adrenal glands and reproductive organs. Some cholesterol  is absorbed from dietary sources. The largest concentration of cholesterol is in the myelin sheath that surrounds nerves and in the plasma membrane that surrounds all cells in vertebrates (25% of brain lipid is cholesterol). Cholesterol can be esterified with a fatty acid to form cholesteryl esters which form discrete lipid droplets in cells, especially in cells of steroidogenic tissues, and in the lipid core of low-density lipoproteins in the blood. The collection on the walls of arteries interferes with the flow of blood. The High level of cholesterol in the blood is a major risk factor for coronary heart diseases.