Product name | Pitavastatin Calcium |
CAS No. | 147526-32-7 |
Molecular Formula | (C25H23FNO4)2.Ca |
Molecular Weight | 880.98 |
Quality Standard | 99% up by HPLC, GMP,JP |
Appearance | White or pale yellow powder |
COA of Pitavastatin Calcium |
ITEMS | SPECIFICATION | RESULT |
Appearance | White or pale yellow powder | Conforms |
Solubility | Slightly soluble in methanol, very slightly soluble in water and ethannol. It dissolves in dilute hydrochloric acid. | Conforms |
Specific optical rotation | +22.0。~ +24.50。 | +23.6。 |
Identity | Chemical reaction: Positive | Positive |
UV: Should conform to reference spectrum | Conforms |
IR: Should conform to standard | Conforms |
Related substance | Any individual impurity ≤ 0.1% Enantiomer of Pitavastatin ≤ 0.1% RRT1.1 ≤ 0.5% Total impurity ≤ 1.5% | 0.08% Undetected 0.15% 0.4% |
Heavy metals | ≤ 20ppm | Conforms |
Water | 9.0%-13.0% | 10.0% |
Assay | 98.0～102.0%(anhydrous substance ) | 101.0% |
Conclusion | The results above meet all requirements under JP16
|
Function of Pitavastatin calcium
Pitavastatin calcium is a statin drug. It inhibits cholesterol synthesis. By inhibiting cholesterol synthesis, it reduces the content of low-density lipoprotein cholesterol and total cholesterol in plasma, so it is a lipid-lowering drug.
Who is pitavastatin used for?
1. People have imple hypercholesterolemia, with relatively high blood lipid levels, requires treatment to reduce low-density lipoprotein cholesterol, and the drug can be stopped after the blood lipids drop.
2. People with some manifestations of atherosclerosis, such as those who can see obvious plaques on carotid ultrasound, and whose blood lipid levels need to be controlled to a lower level.
3. People with coronary heart disease or cerebral atherosclerosis, or very obvious peripheral atherosclerosis, he has atherosclerotic cardiovascular and cerebrovascular disease, he must take statin for life, pitavastatin can be used for a long time . It mostly brings it down to the guideline-recommended value for LDL cholesterol, not the value for LDL cholesterol on the test sheet.
