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Merck
CN

PHR1928

瑞舒伐他汀钙

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

罗伐他汀 钙盐

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关于此项目

经验公式（希尔记法）:
C44H54CaF2N6O12S2
化学文摘社编号:
147098-20-2
分子量:
1001.14
UNSPSC Code:
41116107
NACRES:
NA.24

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产品名称

瑞舒伐他汀钙, Pharmaceutical Secondary Standard; Certified Reference Material

SMILES string

[Ca+2].Fc3ccc(cc3)c4nc(nc(c4\C=C\[C@@H](O)C[C@@H](O)CC(=O)[O-])C(C)C)N([S](=O)(=O)C)C.Fc1ccc(cc1)c2nc(nc(c2\C=C\[C@@H](O)C[C@@H](O)CC(=O)[O-])C(C)C)N([S](=O)(=O)C)C

InChI

1S/2C22H28FN3O6S.Ca/c2*1-13(2)20-18(10-9-16(27)11-17(28)12-19(29)30)21(14-5-7-15(23)8-6-14)25-22(24-20)26(3)33(4,31)32;/h2*5-10,13,16-17,27-28H,11-12H2,1-4H3,(H,29,30);/q;;+2/p-2/b2*10-9+;/t2*16-,17-;/m11./s1

InChI key

LALFOYNTGMUKGG-BGRFNVSISA-L

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0001719
traceable to USP 1606015

API family

rosuvastatin

form

powder

CofA

current certificate can be downloaded

packaging

pkg of 1 g

application(s)

pharmaceutical

storage temp.

-10 to -25°C

Quality Level

300

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相关类别

Analysis Note

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

Application

This pharmaceutical secondary standard can also be used as follows:

  • Spectrophotometric estimation of rosuvastatin calcium in its pure form and tablet formulations
  • Determination of rosuvastatin calcium by square-wave voltammetry using a boron-doped diamond electrode in two tablet samples and biological fluid samples of human urine and serum
  • Simultaneous quantification of rosuvastatin and amlodipine by high-performance liquid chromatography (HPLC) in combined pharmaceutical formulations
  • Determination of rosuvastatin calcium and related substances in tablets of rosuvastatin using a reversed-phase high-performance liquid chromatographic (RP-HPLC) method

General description

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.

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Rosuvastatin Calcium, an HMG-CoA reductase inhibitor, belongs to the statins class of pharmaceuticals and is used for the treatment of hypercholesterolemia.

Other Notes

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.
To see an example of a Certificate of Analysis for this material enter LRAC2081 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

存储类别

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

分析证书(COA)

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Square-wave voltammetric determination of rosuvastatin calcium in pharmaceutical and biological fluid samples using a cathodically pretreated boron-doped diamond electrode
Silva TA, et al.
Diamond and Related Materials, 58, 103-109 (2015)
Spectrophotometric determination of rosuvastatin calcium in pure form and pharmaceutical formulations by the oxidation using iodine and formation triiodide complex in acetonitrile
Ramadan AA, et al.
International Journal of Pharmacy and Pharmaceutical Sciences, 6, 579-585 (2014)
Simultaneous estimation of rosuvastatin and amlodipine in pharmaceutical formulations using stability indicating HPLC method
Ashfaq M, et al.
Brazilian Journal of Pharmaceutical Sciences , 50, 629-638 (2014)

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