Atorvastatin powder
CAS.NO:134523-00-5
structural formula:C33H35FN2O5
EINECS.no:806-698-0
Other names:Atorvastatin free ACID;Atrovastitne
Test Method:HPLC/UV/GC-MS
MOQ & Package: 10g,100g,1kg,5kg,10kg,25kg etc
Customer's rights and interests:Over 10kg, you can enjoy the service of giving away free samples.
Certificate：FDA,ISO,COA, HPLC, MSDS,TDS etc
Lead Time: 1-3 days
Shipping: DHL,Germany DHL,Germany DPD,UPS,USPS,FedEx,EMS,By Air,By Sea,multimodal transport etc
Store & Shelf life; Cool & dry place; 36 months
Company advantages: there are self-built overseas warehouses and third-party overseas warehouses on all continents.
- Product Description
Xi'an Faithful BioTech Co., Ltd: Your Trusted Atorvastatin powder Manufacturer & Supplier
Statins, as the basic products to strengthen blood lipid control and reduce cardiovascular diseases, are also the long-term concern of many patients with cardiovascular diseases, especially the third generation of Atorvastatin powder provided and introduced by Xi'an Faithful BioTech Co., Ltd company,It is even more popular among the current hot topics! Studies have shown that if your blood lipid level has decreased after using low and medium doses of atorvastatin, but it has not reached the expected control goal, you can consider using it in combination with other types of lipid-lowering pharmaceutical raw materials.
Atorvastatin powder Introduction
Atorvastatin powder is a selective and competitive inhibitor of HMG CoA reductase, which reduces cholesterol biosynthesis in the liver by inhibiting the rate limiting enzyme in cholesterol synthesis, thereby lowering plasma total cholesterol and low-density lipoprotein cholesterol (LDL-C) levels. At the same time, it can increase the number of LDL receptors on the surface of liver cells, enhance LDL uptake and catabolism, and reduce LDL generation and particle count. In addition, it can lower very low-density lipoprotein cholesterol (VLDL-C) and triglyceride (TG) levels, and slightly increase high-density lipoprotein cholesterol (HDL-C) levels. In clinical application, atorvastatin API powder is mainly used to treat patients with primary hypercholesterolemia, mixed hyperlipidemia, coronary heart disease or coronary heart disease (such as diabetes, symptomatic atherosclerotic diseases, etc.) and hypercholesterolemia or mixed dyslipidemia. For patients with homozygous familial hypercholesterolemia, high purity atorvastatin can be used in combination with other lipid-lowering therapies or alone.
Specifications
Item | Specifications | Results |
Appearance | White or almost white powder | Complies |
Identification | HNMR and HPLC retention time. | Complies |
Solubility | Slightly soluble in water，Easily soluble in methanol | Complies |
Water determination | ≤ 3.5% | 0.08% |
Residual solvents | Ethanol : ≤ 5000ppm Tothene: ≤ 890ppm N-Hexane: ≤ 290ppm | Negative 158ppm Negative |
Enantiomer atorvstatin calcium E | ≤ 0.5% | 0.03% |
Related substances | Impurity A: ≤ 0.2% Impurity B: ≤ 0.3% Impurity C: ≤ 0.3% Impurity D: ≤ 0.1% Unspecified impurity: ≤ 0.1% Total: ≤1.0% | 0.1% 0.04% 0.04% 0.07% 0.1% 0.5% |
Loss on drying | ≤1.0% | 0.8% |
Residue on ignition | ≤0.5% | 0.4% |
Heavy Metals | ≤10ppm | 2ppm |
Pb | ≤1ppm | 0.3ppm |
As | ≤1ppm | Negative |
Hg | ≤1ppm | Negative |
Cd | ≤1ppm | Negative |
（HPLC）Purity | ≥98.0% | 98.8% |
Total bacteria count | <1000 cfu/g | 1.28 cfu/g |
Yeast and Moulds | <100 cfu/g | 0.8 cfu/g |
Escherichia Coli | Negative | Negative |
Salmonella | Negative | Negative |
| Conclusion | Conform with enterprise specification （USP 41）. |
Why Choose Us?
Choose our atorvastatin bulk raw powder, and you will get high-quality products with high purity, strict quality inspection and stable supply. We adopt the advanced chemical-enzymatic synthesis process, and the purity of the product is over 99.5%, the related substances are less than 1.0%, and the heavy metals are less than ≤10ppm, which meets the international pharmacopoeia standards such as CP, USP and BP. We have a perfect supply chain system, with sufficient annual production capacity, which can meet the needs of large-scale procurement, and provide complete technical data and quality analysis reports. The professional team can respond to your technical consultation and customized service needs at any time. My email is: sales8@faithfulbio.com ,Welcome to the store for inquiries.
What is the difference between atorvastatin and ezetimibe in lipid-lowering principle?
There are two sources of cholesterol in the human body, one is synthesized by the liver of human organs, and the other is absorbed through the intestine. Atorvastatin powder can reduce blood lipid by reducing the synthesis of cholesterol, and ezetimibe API can reduce blood lipid by inhibiting the absorption of cholesterol in small intestine.
In addition to lowering blood lipids, atorvastatin can also stabilize atherosclerotic plaques and inhibit vascular inflammation. Inflammation can cause platelet aggregation and damage the intima of blood vessels. Therefore, atorvastatin API can reduce the possibility of cardiovascular diseases in many ways, and the role of ezetimibe in these aspects is very limited.
Generally, the adverse reactions of atorvastatin increase with the increase of dosage. Common adverse reactions include abnormal liver function and muscle damage. The safety and tolerance of ezetimibe are good, and its adverse reactions are mild and mostly transient, mainly manifested as headache and digestive tract symptoms.
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FAQ
Q1.What are the main synthetic methods of atorvastatin?
The preparation methods of atorvastatin mainly include racemic separation, diastereoselective condensation, Paal Knorr synthesis, cycloaddition, and dicarbonyl asymmetric reduction. These methods can also be divided into linear synthesis and convergent synthesis. The main ring and side chains are synthesized separately in the aggregation synthesis method, which is easy to control in quality, simple and easy to operate, and the target product is easy to separate and purify. It is more economical and practical than the linear synthesis method.
Q2.What are the advantages of the aggregation synthesis process?
Adopting the aggregation method synthesis strategy, ATS-9 is used as the starting material to form a salt with mevalonate, and then ATS-9 mevalonate and M4 are used as raw materials to aggregate and synthesize high-purity intermediate L1, followed by acid hydrolysis, alkaline hydrolysis, and refining. This process has mild reaction conditions, high conversion rates, and economically accessible raw materials, greatly reducing production costs and suitable for large-scale industrial production. The total yield can reach 77.73%, and the purity of atorvastatin API Powder is 99.86%, which is currently the main synthesis method of our company.
Q3.What is the market outlook for atorvastatin?
Atorvastatin is currently one of the most widely used drugs in clinical practice for regulating blood lipids and preventing cardiovascular disease, with over 137 countries currently using it. With the rising incidence of cardiovascular disease and hyperlipidemia and the acceleration of population aging, the market of atorvastatin powder has gradually rebounded, and the prospect is still promising.
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It is estimated that from 2025 to 2030, the compound annual growth rate of the global atorvastatin API market will be 5.8%, and the scale will reach 1.5 billion US dollars. Among them, the high prevalence of cardiovascular diseases will be the main driving force of the market. High triglyceride levels and LDL cholesterol caused by obesity and sedentary lifestyle can help the atorvastatin market. If you want to get corresponding support before this market is launched, please contact us. Our email address is:sales8@faithfulbio.com).
