7-beta,8-beta(2s*,4s*),8a-beta))-alph
Simvastatin
CAS: 79902-63-9
Molecular Formula: C25H38O5
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Names and Identifiers
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Physico-chemical Properties
| Molecular Formula | C25H38O5 |
| Molar Mass | 418.57 |
| Density | 1.11±0.1 g/cm3(Predicted) |
| Melting Point | 127-132 °C (lit.) |
| Boling Point | 564.9±50.0 °C(Predicted) |
| Specific Rotation(α) | D25 +292° (c = 0.5% in acetonitrile) |
| Flash Point | 184.8°C |
| Solubility | Easily soluble in ethanol, acetone or acetonitrile, more difficult to dissolve in ether, almost insoluble in water. |
| Vapor Presure | 4.12E-15mmHg at 25°C |
| Appearance | White crystalline powder |
| Color | white |
| Merck | 14,8539 |
| pKa | 13.49±0.40(Predicted) |
| Storage Condition | 2-8°C |
| Stability | Stable for 2 years as supplied. Solutions in DMSO or ethanol may be stored at -20°C for up to 2 months. |
| Sensitive | Sensitive to humidity and air |
| Refractive Index | 1.53 |
| MDL | MFCD00072007 |
| Physical and Chemical Properties | White crystalline powder, odorless. Soluble in ethanol, acetone or acetonitrile, more difficult to dissolve in ether, a few insoluble in water. The melting point was 135-138 °c. |
| Use | Has the effect of lowering cholesterol, low density lipoprotein cholesterol and very low density lipoprotein cholesterol |
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Risk and Safety
| Hazard Symbols | Xi - Irritant |
| Risk Codes | 36/37/38 - Irritating to eyes, respiratory system and skin. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 - Wear suitable protective clothing. S24/25 - Avoid contact with skin and eyes. |
| WGK Germany | 2 |
| RTECS | EK7798000 |
| HS Code | 29322090 |
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Reference
| Reference Show more | 1. Zhang Yuexiao, Li Ping, Li Bingqing, Chen Jian. Effect of simvastatin on proliferation of esophageal cancer cells through NF-κB p65 pathway [J]. Chinese Journal of pathophysiology, 2020,36(09):1690-1695. 2. [IF = 8.456] Hongfei Qi et al."Electrophonic Deposition of Bioadaptive Drug Delivery coating on Magnesium Alloy for Bone Repair. Acs Appl Mater Inter. 2019;11(8):8625-8634 3. [IF = 2.69] Xiaowei Yuan et al." Using co-axial electrospray deposition to elyminate burst release of simvastatin from microparticles and to enhance induced Genesis. "J Biomat Sci-Polym E. 2019;30(5):355-375 4. [IF = 11.161] Feng Jiao et al."Simvastatin re-sensitizes hepatocellular carcinoma cells to sorafenib by inhibiting HIF-1α/PPAR-γ/PKM2-mediated glycolysis."J Exp Clin Canc Res. 2020 Dec;39(1):1-18 5. [IF=3.24] Bingli Zhao et al."Anti-obesity effects of Spirulina platensis protein hydrolysate by modulating brain-liver axis in high-fat diet fed mice."Plos One. 2019 Jun;14(6):e0218543 6. [IF=2.1] Yuyan Zhang et al."Tanshinone I and simvastatin inhibit melanoma tumour cell growth by regulating poly (ADP ribose) polymerase 1 expression."Mol Med Rep. 2021 Jan;23(1):1-1 7. [IF=4.33] Le Gu et al."Study on chemical constituents of Folium Artemisiae argyi Carbonisatum, toxicity evaluation on zebrafish and intestinal hemostasis."Saudi Pharm J. 2022 Mar;: 8. [IF=4.24] Dan Zhang et al."Assessment of the anti-tumor activity of cyanidin-3-O-arabinoside from apple against APN, JAK, and EZH2 target proteins."Food Bioscience. 2022 May;:101788 |
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Nature
Open Data Verified Data
white crystalline powder, odorless. Soluble in ethanol, acetone or acetonitrile, more difficult to dissolve in ether, almost insoluble in water. The melting point was 135-138 °c.
Last Update：2024-01-02 23:10:35
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Preparation Method
Open Data Verified Data
lovastatin is reacted with N-butylamine, and the resulting compound is dissolved in dimethylformamide, imidazole and tert-butyldimethylsilyl chloride are added, and the reaction is heated at 60 °c. The obtained product was dissolved in a tetrahydrofuran-cyclohexane solution, a pyrrolidinyl lithium solution was added, and methyl iodide was further added to conduct a methylation reaction. The methylated product was dissolved in methanol, water and methanesulfonic acid were added, and an acidic hydrolysis reaction was carried out, and an alkaline hydrolysis reaction was carried out in an aqueous solution of sodium hydroxide. The hydrolysate was suspended in toluene and heated for cyclization to obtain simvastatin.
Last Update：2022-01-01 09:10:59
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Standard
Authoritative Data Verified Data
This product is 2, 2-dimethylbutanoic acid (4R,6R)-6-[2-[(1S,2S,6R,8S,8aR)-1,2,6,7,8,8a-hexahydro-8-hydroxy-2, 6-dimethyl-1-naphthyl] ethyl] tetrahydro-4-hydroxy-2h-pyran-2-one -8-ester. Based on the dry product, the content of C25H3805 should be 98.0% ~ 102.0%.
Last Update：2024-01-02 23:10:35
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Trait
Authoritative Data Verified Data
- This product is white or off-white powder or crystalline powder.
- This product is soluble in acetonitrile, ethanol or methanol, insoluble in water.
specific rotation
take this product, precision weighing, add acetonitrile to dissolve and quantitatively dilute to make a solution containing about 5mg per lml, and determine according to law at 25C (General 0621), the specific rotation was 285 ° to 298 °.
Last Update：2022-01-01 11:58:58
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Introduction
This product is a methyl hydroxyglutaryl coenzyme A(HMG-COA) reductase inhibitor, which inhibits the synthesis of endogenous cholesterol and is a blood lipid regulator. Literature shows that it can reduce the content of cholesterol (TC) in serum, liver and aorta of rabbits with hyperlipidemia, and reduce the levels of very low density lipoprotein cholesterol (VLDL-C) and low density lipoprotein cholesterol (LDL-C).
Last Update：2022-10-16 17:28:57
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Use
Open Data Verified Data
developed by Merk Sharp 8L Dohme, Inc., USA. HMC-CoA reductase inhibitors, can reduce the concentration of serum total bile alcohol, inhibit cholesterol synthesis. For the treatment of primary hypercholesterolemia with a cholesterol level of more than 7.8 mmol/L that is ineffective or intolerable with other treatments.
Last Update：2022-01-01 09:10:59
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Differential diagnosis
Authoritative Data Verified Data
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- take this product, dissolve and dilute with acetonitrile to make a solution containing about 10ug per lml, and measure by UV-Vis spectrophotometry (General rule 0401), there is a maximum absorption at the wavelength of 238nm and 247nm.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 962).
Last Update：2022-01-01 11:58:59
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Exam
Authoritative Data Verified Data
Related substances
take the right amount of this product, add solvent [acetonitrile -0.Olmol/L potassium dihydrogen phosphate solution (adjusted to pH 4.0 with phosphoric acid)(60:40)] was dissolved and diluted to make a solution containing about 0.8mg per 1 ml, as a test solution (accurate measurement within 3 hours, take appropriate amount, and quantitatively dilute with solvent to make a solution containing about 4ug per 1 ml, as a control solution, according to the chromatographic conditions under the content determination item, take 10ul of the test solution and the control solution, respectively, and inject the human liquid chromatograph to record the chromatogram. If there is a chromatographic peak in the chromatogram of the test solution that is consistent with the retention time of the lovastatin peak, the peak area shall not be greater than the main peak area of the control solution (0.5% ) , other single impurity peak area shall not be greater than 0.8 times (0.4%) of the main peak area of the control solution, and the sum of other impurity peak areas shall not be greater than 2 times (1.0%) of the main peak area of the control solution. The chromatogram of the test solution is 0.05 times smaller than the main peak area of the control solution.
loss on drying
take this product and dry under reduced pressure at 60°C for 3 hours, and the weight loss shall not exceed 0.5% (General rule 0831).
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metal when examined by law (General rule 0821, Law II).
Last Update：2022-01-01 11:59:00
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane as filler (4.6mm x 33mm,3um or equivalent chromatographic column); Acetonitrile-0.1% phosphoric acid solution (50:50) as mobile phase A ,0.1% phosphoric acid acetonitrile solution as mobile Phase B, the following table gradient elution; Flow rate of 3.0ml per minute; Detection wavelength of 238nm. Take 20mg of simvastatin control, put it in a 50ml measuring flask, add 5ml of 0.2mol/L sodium hydroxide solution-acetonitrile (1:1) mixed solution, shake to dissolve, and place it for 5 minutes, after neutralization with dilute hydrochloric acid, dilute to the scale with the solvent under the item of related substances to obtain simvastatin acid solution containing ring-opening degradation product; Take about 2mg each of lovastatin and simvastatin and put it in the same 100ml measuring flask, add 5ml simvastatin acid solution, dissolve with solvent and dilute to the scale, shake, as the system applicable solution, take 10u1 injection liquid chromatograph, record chromatogram, the separation degree between simvastatin acid peak and lovastatin peak should meet the requirements, and the separation degree between lovastatin peak and simvastatin peak should be greater than 4.0.
assay
take about 40mg of this product, weigh it accurately, put it in a 100ml measuring flask, dissolve it with solvent and dilute it to the scale, shake it well, use it as a test solution, and take l0ul for precision measurement, injection of human liquid chromatograph, record chromatogram; Another simvastatin reference substance, precision weighing, the same method for determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:59:01
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Category
Authoritative Data Verified Data
hypolipidemic drugs.
Last Update：2022-01-01 11:59:01
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Storage
Authoritative Data Verified Data
sealed, filled with nitrogen, stored in a cool place.
Last Update：2022-01-01 11:59:01
7-beta,8-beta(2s*,4s*),8a-beta))-alph - SimvastatinTablets
Authoritative Data Verified Data
This product contains simvastatin (C25H3805) should be labeled the amount of 90.0% ~ 110.0%.
trait
This product is white or white-like tablets or film-coated tablets, white or white-like after removing the coating.
identification
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- take an appropriate amount of the fine powder of this product and add an appropriate amount of solvent I [acetonitrile -0.05mol/L sodium acetate solution (adjust the pH value to 4.0 with glacial acetic acid) (8:2)], shake to dissolve simvastatin and dilute to make a solution containing simvastatin 10% per 1 ml, filter, take the filtrate, according to UV-visible spectrophotometry (General 0401) determination, at 231nm, there is a maximum absorption at the wavelength of 238nm and 247nm.
examination
- Related substances take an appropriate amount of fine powder of this product (about 80mg equivalent to simvastatin), put it in a 100ml measuring flask, add an appropriate amount of solvent II (with the solvent under the item of simvastatin related substances), and fully shake it, dissolve simvastatin and dilute to the scale, shake, filter, and take the filtrate as a test solution (1 ml for precision measurement within 3 hours, put it in a 100ml measuring flask, as a control solution, it was diluted to the scale with solvent II and shaken. According to the method of simvastatin related substances. If there are impurity peaks in the chromatogram of the test solution, the peak of the auxiliary material before the relative retention time of 0.3 times shall be subtracted, and the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0% ) , the sum of each impurity peak area shall not be greater than 3 times (3.0%) of the main peak area of the control solution. The chromatogram of the test solution is 0.05 times smaller than the main peak area of the control solution.
- Content uniformity take 1 tablet of this product, put it in 50ml(5mg specification), 100ml(lOmg specification) or 200ml(20mg specification) measuring flask, and add identification (2) appropriate amount of the mixed solution under the item, fully shake to dissolve simvastatin, dilute to the scale with the mixed solution, shake, filter, take the filtrate, and determine the content according to the method under the content determination item, the provisions shall be met (General rule 0941).
- dissolution of this product, according to the dissolution and release determination method (General 0931 second method), with 0.5% sodium dodecyl sulfate 0.Olmol/L sodium dihydrogen phosphate buffer (adjusted to pH 50% with 7.0 sodium hydroxide solution) ml as dissolution medium, rotating at 50 rpm, operated according to law, after 30 minutes, take 10ml of solution, filter, the continued filtrate was taken as the test solution. Another simvastatin reference substance was carefully weighed, dissolved and quantitatively diluted with dissolution medium to make 6ug(5mg specification), 12ug (10 mg specification) and 24ug(20ml specification) per lml. Or 48UG (40mg specification) of the solution as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and 20 u1 of the reference solution are respectively injected into the human liquid chromatograph, the chromatogram is recorded, and the dissolution amount of each tablet is calculated by the peak area according to the external standard method. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; 0.025mol/L sodium dihydrogen phosphate solution (with phosphoric acid or sodium hydroxide solution to adjust the pH value to 4.5)-acetonitrile (35:65) as mobile phase; The detection wavelength is 238nm, take the appropriate amount of simvastatin control and lovastatin control, dissolve and dilute with solvent I to make a solution containing about 20ug in each lml, 20m1 injection liquid chromatograph, the separation degree between simvastatin peak and lovastatin peak should be greater than 3, the number of theoretical plate according to simvastatin peak calculation is not less than 2000.
- determination of 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 10mg equivalent to simvastatin), put in a 100ml measuring flask, add an appropriate amount of solvent I, the simvastatin was dissolved by ultrasound, diluted to the scale with solvent I, shaken well, filtered, and the filtrate was taken as the sample liquid, and 20 ml was injected into the human liquid chromatograph with precise volume, and the chromatogram was recorded; take another simvastatin control, precision weighing, plus solvent I to dissolve and quantitatively dilute to make about 0 per 1 ml. lmg solution, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
same with simvastatin.
specification
(l)5mg (2)10mg (3)20mg (4)40mg
storage
shade, seal, and store in a cool place.
Last Update：2022-01-01 11:59:02
7-beta,8-beta(2s*,4s*),8a-beta))-alph - Simvastatin Capsules
Authoritative Data Verified Data
This product contains simvastatin (C25H38O5) should be 90.0% to 110.0% of the label.
trait
The content of this product is white or white particles or powder.
identification
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- take an appropriate amount of the contents of this product and add an appropriate amount of solvent I [acetonitrile -0.05mol/L sodium acetate solution (adjust pH value to 4.0x8: 2 with glacial acetic acid)], shake to dissolve and dilute simvastatin to make a solution containing 10ug of simvastatin per 1 ml, filter, take the filtrate, according to UV-visible spectrophotometry (General 0401) determination, in 231mn, there is a maximum absorption at the wavelength of 238mn and 247mn.
examination
- Related substances take an appropriate amount of the contents of this product (about 80mg equivalent to simvastatin), put it in a 100ml measuring flask, add an appropriate amount of solvent II (solvent under the item of related substances of simvastatin), and fully shake it, dissolve simvastatin and dilute to the scale, shake, filter, and take the filtrate as the test solution (measured within 3 hours); Take 1ml of precision measurement and put it in a 100ml measuring flask, diluted with solvent n to the scale, shake, as a control solution; According to the method under the item of simvastatin related substances. If there are impurity peaks in the chromatogram of the test solution, the peak of the auxiliary material before the relative retention time of 0.3 times shall be subtracted, and the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (1.0%), the sum of each impurity peak area shall not be greater than 3 times (3.0%) of the main peak area of the control solution. The chromatogram of the test solution is 0.05 times smaller than the main peak area of the control solution.
- Content uniformity: Take 1 capsule of this product and pour the content into a 50ml(5mg specification), 100ml(10mg specification) or 200ml(20mg specification) measuring bottle, the capsule shell is washed with the mixed solution under Item (2) of identification, washed with the same measuring flask, added with the appropriate amount of mixed solution, fully shaken to dissolve simvastatin and diluted to the scale, shake well, filter, take and continue the filtrate, and determine the content according to the method under the content determination item, which shall comply with the regulations (General rule 0941).
- dissolution of this product, according to the dissolution and release determination method (General 0931 first method), with 0.5% sodium dodecyl sulfate O.Olmol/L sodium dihydrogen phosphate buffer (adjusted to pH 50% with 7.0 sodium hydroxide solution) 100 ml as dissolution medium, rotating speed of RPM, operated according to law, after 30 minutes, take 10ml of solution, filter, the continued filtrate was taken as the test solution. Take an appropriate amount of simvastatin reference substance, precision weighing, dissolution medium and quantitative dilution of 6ug( 5mg specification), 12ug ( 10mg specification), 24ug( 20mg specification) per lml or 48UG (40mg specification) of the solution, as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the reference solution are respectively injected into the liquid chromatograph, and the dissolution amount of each tablet is calculated by the peak area according to the external standard method. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; 0.025mol/L sodium dihydrogen phosphate solution (with phosphoric acid or sodium hydroxide solution to adjust the pH value to 4.5)-acetonitrile (35:65) as the mobile phase; The detection wavelength is 238nm, take the appropriate amount of simvastatin and lovastatin, add solvent I to dissolve and dilute to make a solution containing about 20ug in each lml, take 20u1 into the liquid chromatograph, the degree of separation between simvastatin peak and lovastatin peak should be more than 3.0, and the number of theoretical plates should not be less than 2000 according to the simvastatin peak.
- determination Method: Take 20 capsules of this product, weigh them precisely, calculate the average loading amount, pour out the contents or take the contents (40mg specification) under the item of difference in loading amount, mix evenly and grind finely, take an appropriate amount (about 10mg of simvastatin), put it in a 100ml measuring flask, add an appropriate amount of solvent I, ultrasonic to dissolve simvastatin, dilute to the scale with solvent I, shake well, filter, the continued filtrate was taken as the test solution, and 20u1 was accurately measured and injected into the human liquid chromatograph to record the chromatogram, solubilizer I was dissolved and quantitatively diluted to make about 0.lmg solution, the same method for determination. According to the external standard method to calculate the peak area, that is.
category
same with simvastatin.
specification
(l)5mg (2)10mg (3)20mg (4)40mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:59:03
Supplier List
Product Name: Simvastatin Request for quotation
CAS: 79902-63-9
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
CAS: 79902-63-9
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
Multiple SpecificationsSpot supply
Product Name: Simvastatin Visit Supplier Webpage Request for quotationCAS: 79902-63-9
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
Product Name: SIMVASTATIN Request for quotation
CAS: 79902-63-9
Tel: +86-571-88162785
Email: Lucy@verypharm.com
Mobile: +86-13606544505
QQ: 472954302
Product List: View Catalog
CAS: 79902-63-9
Tel: +86-571-88162785
Email: Lucy@verypharm.com
Mobile: +86-13606544505
QQ: 472954302
Product List: View Catalog
Product Name: Simvastatin Request for quotation
CAS: 79902-63-9
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
CAS: 79902-63-9
Tel: 0086-551-65418684
Email: sales@tnjchem.com
info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840
Wechat: 0086 189 4982 3763
WhatsApp: 0086 189 4982 3763
Product List: View Catalog
Multiple SpecificationsSpot supply
Product Name: Simvastatin Visit Supplier Webpage Request for quotationCAS: 79902-63-9
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
QQ: 3008007409
Wechat: 18301782025
Product Name: SIMVASTATIN Request for quotation
CAS: 79902-63-9
Tel: +86-571-88162785
Email: Lucy@verypharm.com
Mobile: +86-13606544505
QQ: 472954302
Product List: View Catalog
CAS: 79902-63-9
Tel: +86-571-88162785
Email: Lucy@verypharm.com
Mobile: +86-13606544505
QQ: 472954302
Product List: View Catalog
View History