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Merck

PHR1438

Supelco

Simvastatin

Pharmaceutical Secondary Standard; Certified Reference Material

Synonim(y):

Simvastatin

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About This Item

Wzór empiryczny (zapis Hilla):
C25H38O5
Numer CAS:
Masa cząsteczkowa:
418.57
Numer MDL:
Kod UNSPSC:
41116107
Identyfikator substancji w PubChem:
NACRES:
NA.24

klasa czystości

certified reference material
pharmaceutical secondary standard

Poziom jakości

agency

traceable to BP 739
traceable to Ph. Eur. S0650000
traceable to USP 1612700

rodzina API

simvastatin

Certyfikat analizy

current certificate can be downloaded

metody

HPLC: suitable
gas chromatography (GC): suitable

mp

127-132 °C (lit.)

Zastosowanie

pharmaceutical (small molecule)

Format

neat

temp. przechowywania

-10 to -25°C

ciąg SMILES

[H][C@]12[C@H](C[C@@H](C)C=C1C=C[C@H](C)[C@@H]2CC[C@@H]3C[C@@H](O)CC(=O)O3)OC(=O)C(C)(C)CC

InChI

1S/C25H38O5/c1-6-25(4,5)24(28)30-21-12-15(2)11-17-8-7-16(3)20(23(17)21)10-9-19-13-18(26)14-22(27)29-19/h7-8,11,15-16,18-21,23,26H,6,9-10,12-14H2,1-5H3/t15-,16-,18+,19+,20-,21-,23-/m0/s1

Klucz InChI

RYMZZMVNJRMUDD-HGQWONQESA-N

informacje o genach

human ... HMGCR(3156)

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Opis ogólny

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to in-house working standards.
Simvastatin is a hypolipidemic drug, which lowers plasma cholesterol by inhibiting 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase. It is widely used in the treatment of hypercholesterolemia.

Zastosowanie

Simvastatin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Działania biochem./fizjol.

Simvastatin is a specific inhibitor of HMG-CoA reductase and cholesterol lowering drug.
Simvastatin is a specific inhibitor of HMG-CoA reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early step in cholesterol biosynthesis. It is used in the treatment of hypercholesterolemia, as it reduces levels of low-density lipoproteins and triglycerides, and raises high-density lipoprotein levels. Simvastatin is a lactone that is readily hydrolyzed in vivo to the corresponding β-hydroxyacid, and can be activated prior to use with NaOH in EtOH treatment. It is a synthetic analog of lovastatin (Cat. No. M2147).

Komentarz do analizy

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Inne uwagi

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Przypis

To see an example of a Certificate of Analysis for this material enter LRAB3719 in the slot below. This is an example certificate only and may not be the lot that you receive.

Polecane produkty

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.
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Piktogramy

Health hazard

Hasło ostrzegawcze

Warning

Zwroty wskazujące rodzaj zagrożenia

Zwroty wskazujące środki ostrożności

Klasyfikacja zagrożeń

Repr. 2

Kod klasy składowania

11 - Combustible Solids

Klasa zagrożenia wodnego (WGK)

WGK 3

Temperatura zapłonu (°F)

Not applicable

Temperatura zapłonu (°C)

Not applicable


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Certyfikaty analizy (CoA)

Lot/Batch Number

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Klienci oglądali również te produkty

Simultaneous determination of ezetimibe and simvastatin in pharmaceutical formulations by dual-mode gradient LC.
Ozalt?n N & Ucakturk E
Chromatographia, 66(1), 87-91 (2007)
Development of self-microemulsifying drug delivery systems (SMEDDS) for oral bioavailability enhancement of simvastatin in beagle dogs.
Kang BK, et al.
International Journal of Pharmaceutics, 274(1-2), 65-73 (2004)
HPLC determination of ezetimibe and simvastatin in pharmaceutical formulations.
Ashfaq M, et al.
Journal of the Chilean Chemical Society, 52(3), 1220-1223 (2007)
Determination of lovastatin and simvastatin in pharmaceutical dosage forms by MEKC.
Srinivasu MK, et al.
Journal of Pharmaceutical and Biomedical Analysis, 29(4), 715-721 (2002)
A Marot et al.
Acta clinica Belgica, 66(2), 134-136 (2011-06-03)
Myopathy, including rhabdomyolysis, is a well-known, albeit rare complication of statin therapy. Predisposing factors include comorbidities and the concomitant use of cytochrome P-450 (CYP) 3A4 inhibitors. We report a case of severe simvastatin-induced rhabdomyolysis triggered by the addition of amiodarone

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