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PHR1422

Supelco

Atorvastatin Calcium

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

Atorvastatin hemicalcium salt sesquihydrate, 1H-Pyrrole-1-heptanoic acid, [R-(R*,R*)]-2-(4-flurophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl], calcium salt (2:1)

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About This Item

Formula empirica (notazione di Hill):
C66H68CaF2N4O10 · 3H2O
Numero CAS:
Peso molecolare:
1209.39
Codice UNSPSC:
41116107
NACRES:
NA.24

Grado

certified reference material
pharmaceutical secondary standard

Livello qualitativo

agenzia

traceable to Ph. Eur. Y0001327
traceable to USP 1044516

Famiglia di API

atorvastatin

CdA

current certificate can be downloaded

tecniche

HPLC: suitable
gas chromatography (GC): suitable

applicazioni

pharmaceutical (small molecule)

Formato

neat

Temperatura di conservazione

2-30°C

Stringa SMILE

[Ca+2].Fc5ccc(cc5)c6[n](c(c(c6c8ccccc8)C(=O)Nc7ccccc7)C(C)C)CC[C@@H](O)C[C@@H](O)CC(=O)O.Fc1ccc(cc1)c2[n](c(c(c2c4ccccc4)\C(=N\c3ccccc3)\[O-])C(C)C)CC[C@@H](O)C[C@@H](O)CC(=O)[O-].O.O.O

InChI

1S/2C33H35FN2O5.Ca.3H2O/c2*1-21(2)31-30(33(41)35-25-11-7-4-8-12-25)29(22-9-5-3-6-10-22)32(23-13-15-24(34)16-14-23)36(31)18-17-26(37)19-27(38)20-28(39)40;;;;/h2*3-16,21,26-27,37-38H,17-20H2,1-2H3,(H,35,41)(H,39,40);;3*1H2/q;;+2;;;/p-2/t2*26-,27-;;;;/m11..../s1
SHZPNDRIDUBNMH-NIJVSVLQSA-L

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Descrizione generale

Atorvastatin Calcium is a synthetic cholesterol lowering agent, which acts as an inhibitor of 3-hydroxy-3-methyl glutaryl coenzyme A reductase. It is widely used in combination with amlodipine besylate as a medication in the treatment of vasospastic angina, hypertension, chronic stable angina and primary dysbetalipoproteinemia.
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.

Applicazioni

Azathioprine may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using reversed-phase high-performance liquid chromatography (RP-HPLC) and spectrophotometric 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.

Risultati analitici

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

Altre note

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.

Nota a piè di pagina

To see an example of a Certificate of Analysis for this material enter LRAC0148 in the slot below. This is an example certificate only and may not be the lot that you receive.

Analita

Descrizione

    Atorvastatin hemicalcium salt sesquihydrate

Colonna analitica

Prodotti correlati

N° Catalogo
Descrizione
Determinazione del prezzo

Pittogrammi

Health hazard

Avvertenze

Danger

Indicazioni di pericolo

Classi di pericolo

Carc. 2 - Repr. 1B

Codice della classe di stoccaggio

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

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)

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Ezetimibe ≥98% (HPLC)

Sigma-Aldrich

SML1629

Ezetimibe

Simvastatin ≥97% (HPLC), solid

Sigma-Aldrich

S6196

Simvastatin

Simultaneous Spectrophotometric Determination of Atorvastatin Calcium and Ezetimibe in Tablet Dosage Form
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International immunopharmacology, 23(2), 546-549 (2014-12-03)
This study aimed to investigate the efficacy of combined atorvastatin calcium and methylprednisolone for the treatment of multiple sclerosis relapse. Patients with multiple sclerosis (MS) at the relapse phase were randomized to receive either combined treatment of atorvastatin calcium and
Stability indicating RP-HPLC estimation of atorvastatin calcium and amlodipine besylate in pharmaceutical formulations
Shah AD, et al.
Indian Journal of Pharmaceutical Sciences, 70(6), 754-754 (2008)
Yuka Keyamura et al.
PloS one, 9(5), e96929-e96929 (2014-05-09)
Lowering the blood concentration of low-density lipoprotein (LDL) cholesterol is the primary strategy employed in treating atherosclerotic disorders; however, most commonly prescribed statins prevent cardiovascular events in just 30% to 40% of treated patients. Therefore, additional treatment is required for

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