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Merck

PHR1438

Supelco

Simvastatin

Pharmaceutical Secondary Standard; Certified Reference Material

Szinonimák:

Simvastatin

Bejelentkezésa Szervezeti és Szerződéses árazás megtekintéséhez


About This Item

Tapasztalati képlet (Hill-képlet):
C25H38O5
CAS-szám:
Molekulatömeg:
418.57
MDL-szám:
UNSPSC kód:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Minőségi szint

Ügynökség

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

API-család

simvastatin

Analitikai műbizonylat

current certificate can be downloaded

technika/technikák

HPLC: suitable
gas chromatography (GC): suitable

mp

127-132 °C (lit.)

alkalmazás(ok)

pharmaceutical (small molecule)

format

neat

tárolási hőmérséklet

-10 to -25°C

SMILES string

[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

Nemzetközi kémiai azonosító kulcs

RYMZZMVNJRMUDD-HGQWONQESA-N

Géninformáció

human ... HMGCR(3156)

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Általános leírás

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.

Alkalmazás

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.

Biokémiai/fiziológiai hatások

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).

Analízis megjegyzés

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

Egyéb megjegyzések

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.

Lábjegyzet

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.

Javasolt termékek

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.

Piktogramok

Health hazard

Figyelmeztetés

Warning

Figyelmeztető mondatok

Óvintézkedésre vonatkozó mondatok

Veszélyességi osztályok

Repr. 2

Tárolási osztály kódja

11 - Combustible Solids

WGK

WGK 3

Lobbanási pont (F)

Not applicable

Lobbanási pont (C)

Not applicable


Válasszon a legfrissebb verziók közül:

Analitikai tanúsítványok (COA)

Lot/Batch Number

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Az Ön által nemrégiben megvásárolt termékekre vonatkozó dokumentumokat a Dokumentumtárban találja.

Dokumentumtár megtekintése

HPLC determination of ezetimibe and simvastatin in pharmaceutical formulations.
Ashfaq M, et al.
Journal of the Chilean Chemical Society, 52(3), 1220-1223 (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)
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)
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)
Joost Besseling et al.
JAMA, 313(10), 1029-1036 (2015-03-11)
Familial hypercholesterolemia is characterized by impaired uptake of cholesterol in peripheral tissues, including the liver and the pancreas. In contrast, statins increase the cellular cholesterol uptake and are associated with increased risk for type 2 diabetes mellitus. We hypothesize that

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