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Documenti fondamentali

PHR1928

Supelco

Rosuvastatin Calcium

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

Rosuvastatin calcium salt

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About This Item

Formula empirica (notazione di Hill):
C44H54CaF2N6O12S2
Numero CAS:
Peso molecolare:
1001.14
Codice UNSPSC:
41116107
NACRES:
NA.24

Grado

certified reference material
pharmaceutical secondary standard

Livello qualitativo

agenzia

traceable to Ph. Eur. Y0001719
traceable to USP 1606015

Famiglia di API

rosuvastatin

Stato

powder

CdA

current certificate can be downloaded

Confezionamento

pkg of 1 g

applicazioni

pharmaceutical

Temperatura di conservazione

-10 to -25°C

Stringa SMILE

[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
LALFOYNTGMUKGG-BGRFNVSISA-L

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Descrizione generale

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.

Applicazioni

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

Risultati analitici

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

Nota a piè di pagina

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.

Prodotti consigliati

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.

Codice della classe di stoccaggio

11 - Combustible Solids

Classe di pericolosità dell'acqua (WGK)

WGK 3

Punto d’infiammabilità (°F)

Not applicable

Punto d’infiammabilità (°C)

Not applicable


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Certificati d'analisi (COA)

Lot/Batch Number

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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)

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