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Documenti fondamentali

PHR1870

Supelco

Atorvastatin Related Compound C

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

RR)-2,3-Bis(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemicalcium salt

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About This Item

Formula empirica (notazione di Hill):
C66H66CaF4N4O10
Numero CAS:
Peso molecolare:
1191.32
Codice UNSPSC:
41116107
NACRES:
NA.24

Grado

certified reference material
pharmaceutical secondary standard

Livello qualitativo

agenzia

traceable to Ph. Eur. Y0001330
traceable to USP 1044549

Famiglia di API

atorvastatin

CdA

current certificate can be downloaded

Confezionamento

pkg of 30 mg

applicazioni

pharmaceutical

Formato

neat

Temperatura di conservazione

-10 to -25°C

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Descrizione generale

This material is an impurity of atorvastatin. Atorvastatin is a synthetic HMG-CoA reductase inhibitor which lowers plasma cholesterol levels by inhibiting endogenous cholesterol synthesis.
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

Atorvastatin may be used as a pharmaceutical reference standard for the determination of the analyte in drug dosage forms by 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.

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 LRAB7553 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Prodotti correlati

N° Catalogo
Descrizione
Determinazione del prezzo

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


Certificati d'analisi (COA)

Cerca il Certificati d'analisi (COA) digitando il numero di lotto/batch corrispondente. I numeri di lotto o di batch sono stampati sull'etichetta dei prodotti dopo la parola ‘Lotto’ o ‘Batch’.

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Supelco

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Atorvastatin Calcium United States Pharmacopeia (USP) Reference Standard

USP

1044516

Atorvastatin Calcium

Atorvastatin associated liver disease
Clarke, AT and Mills, PR
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 38(10), 772-777 (2006)
An HPLC method for the determination of atorvastatin and its impurities in bulk drug and tablets
Erturk S, et al.
Journal of Pharmaceutical and Biomedical Analysis, 33(5), 1017-1023 (2003)
HPLC methods for the determination of simvastatin and atorvastatin
Novakova L, et al.
TrAC, Trends in Analytical Chemistry, 27(4), 352-367 (2008)

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