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Simvastatin CAS 79902-63-9 Blood System Agents Hypolipidemic agents API GMP

Simvastatin CAS 79902-63-9 Blood System Agents Hypolipidemic agents API GMP

Simvastatin CAS 79902-63-9 Blood System Agents Hypolipidemic agents API GMP

Product Details:

Place of Origin: CHINA
Brand Name: Health Herb
Certification: GMP
Model Number: USP EP

Payment & Shipping Terms:

Minimum Order Quantity: 1KGS
Price: Negotiable
Packaging Details: 20KGS/DRUM
Delivery Time: 7 DAYS
Supply Ability: 10MT/MONTH
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Detailed Product Description
Name: Simvastatin CAS: 79902-63-9
MF: C25H38O5 MW: 418.57
Usage: Hypolipidemic Agents Appearance: White Crystal
Standard: USP EINECS No.: 404-520-2
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We supply good quality Simvastatin CAS 79902-63-9

 

Introduction

 

CAS No.:79902-63-9

Other Names:Simvastatin

MF:C25H38O5

EINECS No.:404-520-2

Place of Origin: Anhui,China (Mainland)

Type:Antipyretic Analgesics and NSAIDs, Auxiliaries and Other Medicinal Chemicals, Blood System Agent

Grade Standard:Medicine Grade

Brand Name:JOYE

Purity:99%min

Appearance :White crystalline powder

Product name:Simvastatin

Molecular Weight:418.57

Color:White

Melting point:139 °C

 

Function

 

Simvastatin is a statin hypolipidemic drugs used to control blood cholesterol levels and prevent cardiovascular disease. Simvastatin is a fermentation product of Aspergillus terreus synthetic derivatives.

 

The primary uses of simvastatin are to treat dyslipidemia and to prevent atherosclerosis-related complications such as stroke and heart attacks in those who are at high risk. It is recommended to be used as an addition to a low-cholesterol diet.

 

In the Scandinavian Simvastatin Survival Study (a placebo-controlled, randomized clinical trial of five years' duration), simvastatin reduced overall mortality in people with existing cardiovascular disease and high LDL cholesterol by 30% and reduced cardiovascular mortality by 42%. The risks of heart attack, stroke, or needing a coronary revascularization procedure were reduced by 37%, 28%, and 37%, respectively.

 

The Heart Protection Study evaluated the effects of simvastatin in people with risk factors including existing cardiovascular disease, diabetes, or stroke, but having relatively low LDL cholesterol. In this trial, which lasted 5.4 years, overall mortality was reduced by 13% and cardiovascular mortality was reduced by 18%. People receiving simvastatin experienced 38% fewer nonfatal heart attacks and 25% fewer strokes.

 

Simvastatin has been used to explore whether statins have an effect on delaying on the onset and progression of age-related macular degeneration (AMD). Results from one trial showed participants assigned to simvastatin had lower odds (0.51 OR) of having AMD progression at three years compared to those assigned to placebo, though the results were not significant. Overall, evidence is insufficient to conclude that simvastatin has an effect in delaying the onset and progression of AMD.

 

Package

 

1kg with double plastic container inside/Aluminum foil bag ;
20kg with double plastic container inside/Fiber drum outside.Or as your request.

1. Stored in a cool and dry well-closed container and in ventilated area.
2. kept away from moisture and strong light or high temperature.
3. Two years under well storage situation and stored away from direct sun light.

 

COA

 

TEST STANDARD RESULT
Characters White to off-white powder A white powder
Identification
  1. IR
Conforms
  1. HPLC
Conforms
Specific optical rotation +285--+298° +290°

 

Solubility

Practically insoluble in water; freely soluble in chloroform, in methanol, and in alcohol; Sparingly soluble in propylene glycol; very slightly soluble in hexane

 

Conforms

Loss On drying ≤0.5 % 0.04%
Residue on Ignition ≤0.1% 0.04%
Heavy Metals ≤20ppm <20ppm
Chromatographic purity
Simvastatin hydroxyacid ≤0.4% 0.09
Lovastatin and epilovastatin ≤1.0% 0.38%
Methylene simvastation ≤0.4% 0.09%
Acetyl simvastatin ≤0.4% 0.05%
Anhydro simvastatin ≤0.4% 0.10%
Simvastatin dimer ≤0.4% 0.11%
Any other individual impurity ≤0.10% 0.03%
Total impurities (except lovastatin and epilovastatin) ≤1.0% 0.52%

Residual organic solvents

Methanol

Ethanol

Methylene chloride

 

≤3000ppm

≤5000ppm

≤600ppm

 

ND

574ppm

ND

Assay (on dry basis) 98.0—102.0% 99.3%
Conclusion It complies with all the requirements of USP34

 

Simvastatin CAS 79902-63-9 Blood System Agents Hypolipidemic agents API GMP

Contact Details
Nanjing Health Herb Bio-Tech Co., Ltd

Contact Person: Pan Lin

Tel: 86-25-83310216

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Tel:86-25-83310216-86638485
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