Audited Supplier
In This Store
Category:Intermediates > Pharmaceutical Intermediates
Product Name:USP/EP Grade Pitavastatin Calcium Raw Material Powder CAS 147526-32-7
CAS No.:147526-32-7
Standard:USP, EP, JP
Price(USD):US$7600~US$8000/Kg
Company:SCM Pioneering Co.,Ltd
Grade: Pharmaceutical Grade
Factory Location: Shandong,China
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa
Monthly Production Capacity: 10000kg
Contract Manufacturing: CMO
Packaging Information: 1kg/bag
Delivery Lead Time: 7-30days
Sample Provided: no
Payment Terms: T/T
USP/EP Grade Pitavastatin Calcium Raw Material Powder
CAS 147526-32-7
Product Description
Pitavastatin calcium is the calcium salt of pitavastatin. Used for treatment of hypercholesterolemia(elevated levels of cholesterol in the blood) on patients unable to sufficiently lower their cholesterol levels by diet and exercise. It has a role as an antioxidant. It is a calcium salt and a statin (synthetic).
| Product name | Pitavastatin calcium | Appearance | White powder | |
| Standard | USP/EP | Solubility | Water Soluble | |
| Formula: | C50H46CaF2N2O8 | CAS: | 147526-32-7 | |
| Tests | Results | Specifications |
| Character | Complies | White to almost white amorphous powder; odorless, tasteless; unstable to light, hygroscopic |
| Solubility | Complies | Should comply |
| Specific optical rotation | +25° | +20°~+26° |
| Specific absorbance | 960 | 960~980 |
Identification |
Complies | Chemistry reaction, should be positive reaction |
| Complies | Chemistry reaction, should be positive reaction | |
| Complies | UV spectrophotometry, should comply | |
| Complies | By IR absorption, to match with the working standard | |
| Complies | Liquid chromatogram, should comply | |
| Flu-orine | 4.1% | 4.0%~5.0%, calculated on the anhydrous basis |
Related substance |
0.1% | Epimer ≤ 0.5% |
| 0.03% | Lactone compounds ≤ 0. 1% | |
| 0. 1% | Other single impurities ≤ 0. 1% | |
| 0.4% | The sum of impurities ≤ 1.0% | |
| Enantiomer | 0.1% | the area of the enantiomer is not more than 0.5 times the principal peak area of the reference solution (0.5%). |
Residual solvent |
0.05% | Me-thanol ≤ 0.3% |
| 0 | Ethanol ≤ 0.5% | |
| 0 | Dichloro me-thane ≤ 0.06% | |
| 0 | Tetrahy drofuran ≤ 0.072% | |
| 0 | Tolu ene ≤ 0.089% | |
| Chloride | Complies | ≤ 0.06% |
Microbial limit |
< 10 cfu/g | Bacterial count: NMT 80 cfu/g |
| < 10 cfu/g | Fungus and yeast count: NMT 10 cfu/g | |
| Absent | Escherichia coli: Absent | |
| Calcium | 4.1% | 4.0%~5.0%, calculated on the anhydrous basis |
| Water | 2.1% | ≤ 3.0% |
| Heavy metals | Complies | ≤ 20ppm |
| Assay(calculated on the dried basis) | 100.2% | ≥ 98.5%(C50H46GaF2N2O8) |
Application
Pivastatin calcium is mainly used to reduce cholesterol and low-density lipoprotein. It is one of the statins that regulate blood lipid. It acts as a rate limiting enzyme in the cholesterol synthesis pathway to reduce the synthesis of cholesterol.
It is often used in the prevention of ischemic cardio cerebrovascular diseases. It can also stabilize atherosclerotic plaque and avoid the occurrence of acute ischemic cardio cerebrovascular events caused by plaque rupture.
Packaging & Shipping
Company Profile
SCM Pioneering Co., Ltd
The professional supplier of food ingredients & additives, SCM Pioneering Co., Ltd is an emerging growth enterprise located in China (Shandong) Pilot Free Trade Zone.
The company was established by a group of experts who have more than twenty years of industry-related experiences, and committed to the development of products that are beneficial to human health and safety.
With our deep knowledge and diligence, together with our associated factories, we would like to provide one-stop sourcing solutions for customers, to save your time and secure your purchasing.
Base everything and anything upon customers' interests and provide quality and value-added services from the date of establishment, SCM Pioneering has a rapid development, with customers in over 25 Countries until 2022, and a variety of high quality food ingredients, like Sweeteners Sucralose, Neotame, Stevia extract, Erythritol, Monk fruit extract, and Nutrition enhancers like Creatine monohydrate, Alpha Lipoic Acid, Coenzyme Q10, L-Glutathione, PQQ.
Thanks for all you concern and support, which is very very precious in our eyes. For any interest in products, services,
information, or cooperation, please feel free to contact us.
we are faithfully looking forward to cooperating with you!
Contact Us
Tel: (+86) 400 610 1188
WhatsApp/Telegram/Wechat: +86 13621645194
Follow Us：
Pharma Sources Insight June 2024: Globalization on the Go
