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Rosuvastatin Calcium API powder

Product Name:Rosuvastatin Calcium API powder
CAS NO.: 147098-20-2
Molecular formula:C22H30CaFN3O6S
EINECS:627-028-1
Synonyms:Rosuvastatin Calium;Rosuvastadine
Shelf life: 24 months
Purity : 98% HPLC
Certificate:COA; HPLC; MSDS; TDS,etc.
MOQ : 1g;10g;100g
Shipping: DHL/FedEx/UPS/USPS Safe and fast delivery
Lead Time: 1-3 days
Warehouse: USA and Germany warehouse
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  • Product Description

Xi'an Faithful BioTech Co., Ltd: Your Trusted Rosuvastatin Calcium API powder Manufacturer & Supplier

Xi'an Faithful BioTech Co., Ltd is the main supplier of Rosuvastatin Calcium API powder. Our production base adopts advanced quality system management systems from abroad, and always strictly controls the procurement, production, and sales processes of raw materials in accordance with quality system requirements. We use advanced testing instruments and complete testing methods to ensure that our products meet international standards. The company is market-oriented and has established friendly and stable trade relationships with more than ten countries and regions including Europe, America, Southeast Asia, Hong Kong, Macao, and Taiwan.

Rosuvastatin Calcium API powder Introduction

Rosuvastatin Calcium API powder is an anti hyperlipidemic drug that belongs to the HMG CoA reductase inhibitor class. It is suitable for treating various lipid abnormalities, including hypercholesterolemia, mixed lipid abnormalities, and simple hypertriglyceridemia. Rosuvastatin Calcium is currently the strongest lipid-lowering and most comprehensive lipid-lowering statin on the market. It has better effects in reducing low-density lipoprotein cholesterol and increasing high-density lipoprotein than Atorvastatin, which is widely recognized as the most effective in the world. Our Rosuvastatin Calcium API powder undergoes strict quality control and has high purity, making it an excellent raw material for the production and research of suitable formulations.

Specifications

Items

Specification

Result

Description

White or off- white powder

Conforms

 

Identification

IR: Positive HPLC: Positive

Water content: Positive

Reaction of calcium: Positive

 

Conforms

 

 

Related Substances

Impurity A 0.2% Impurity A 0.5% Impurity A  0.8%

Any unknown impurity 0.1%

Total impurities  1.2%

 

 

N.D.

Enantiomer

0.15%

0.15%

Calcium(based on anhydrous basis)

3.9~4.3%

4.0%

Water(K.F.)

3.0%

1.9%

Assay (HPLC)

97.0%~102.0%

100.6%

Conclusion:Conform with the enterprise standard.

Why Choose Us?

Quality hardcore, ensuring the efficacy and safety of the formulation from the source

  • High purity control: Raw material purity ≥ 99.8%, key impurities (such as related substances, heavy metals, residual solvents) strictly comply with international and national standards , far below the limit requirements, reducing the risk of impurities in formulation production and ensuring the clinical efficacy of drugs;
  • Mature and stable process: Advanced synthesis technology is adopted, with minimal quality fluctuations between batches and excellent reproducibility, reducing the cost of process adjustments during customer production and improving the yield of finished products.

Stable production capacity ensures uninterrupted supply concerns for customers' production

  • Large scale production: With production bases and sufficient annual production capacity, we can meet customers' full stage raw material needs from research and development trials, pilot tests to commercial large-scale production, without the need for frequent supplier changes;
  • Controllable supply chain: independent production of core intermediates, long-term locking of high-quality suppliers for key raw materials, establishment of a safety stock mechanism, effectively resisting supply risks caused by market fluctuations and policy adjustments.

Main applications

Rosuvastatin calcium API powder is the core raw material for statin lipid-lowering drugs, mainly used in the production of various formulations. Its specific uses are as follows:

  • Production of oral preparations: As the core active ingredient, it is used to manufacture commonly used oral dosage forms such as Rosuvastatin calcium tablets, capsules, and dispersible tablets to meet the medication needs of different patients (such as those with swallowing difficulties and those who need flexible dosage adjustments);
  • Adapt to the research and development of generic drugs/innovative formulations: provide compliant raw materials for pharmaceutical companies, support consistency evaluation of generic drugs, research and registration of innovative dosage forms (such as sustained-release formulations and compound formulations), and assist in the rapid landing of products;
  • To meet clinical medical needs: the final preparation is used to treat hypercholesterolemia (including primary hypercholesterolemia, homozygous familial hypercholesterolemia), mixed dyslipidemia, etc. It is a key drug raw material for cardiovascular disease prevention and treatment by reducing total cholesterol and low-density lipoprotein cholesterol in the blood, increasing high-density lipoprotein cholesterol, reducing the risk of atherosclerosis, and protecting cardiovascular health.

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FAQ

Q1:What is the difference between rosuvastatin and rosuvastatin calcium?

A1:Rosuvastatin Calcium is the calcium salt form of rosuvastatin, a statin with antilipidemic activity.

Q2:What is the mechanism of action of rosuvastatin calcium?

A2:Rosuvastatin Calcium API powder is a selective HMG CoA reductase inhibitor. HMG CoA reductase inhibitor is a rate limiting enzyme that converts 3-hydroxy-3-methylglutaryl-CoA to the precursor of methylvalerate - Cholesterol. The main site of action of Rosuvastatin Calcium is the liver, a targeted organ for cholesterol reduction. It increases the number of receptors on the surface of liver LDL cells, promotes the absorption and breakdown metabolism of LDL, inhibits the hepatic synthesis of VLDL, and thus reduces the total number of VLDL and LDL particles.

Q3:What are the bioavailability and plasma protein binding rate of Rosuvastatin Calcium API powder?

A3:The absolute bioavailability is 20%. The plasma protein binding rate (mainly albumin) is about 90%.

Contact Us

Rosuvastatin Calcium API powder is one of our main products,if you need it for your production and research, please feel free to contact us sales12@faithfulbio.com .

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