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Merck

PHR1422

Supelco

Atorvastatin Calcium

Atorvastatin Calcium

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

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

Fórmula empírica (notación de Hill):
C66H68CaF2N4O10 · 3H2O
Número de CAS:
Peso molecular:
1209.39
Código UNSPSC:
41116107
NACRES:
NA.24
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grado

certified reference material
pharmaceutical secondary standard

Nivel de calidad

Agency

traceable to Ph. Eur. Y0001327
traceable to USP 1044516

familia API

atorvastatin

CofA

current certificate can be downloaded

técnicas

HPLC: suitable
gas chromatography (GC): suitable

aplicaciones

pharmaceutical (small molecule)

Formato

neat

temp. de almacenamiento

2-30°C

cadena SMILES

[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

Clave InChI

SHZPNDRIDUBNMH-NIJVSVLQSA-L

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Descripción general

Atorvastatin Calcium is a synthetic cholesterol lowering agent,[1] 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.[2]
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.

Aplicación

Azathioprine may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations[2][1] using reversed-phase high-performance liquid chromatography (RP-HPLC)[2] and spectrophotometric techniques.[1]
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.

Nota de análisis

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

Otras notas

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 al pie de página

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.

Analito

Descripción

    Atorvastatin hemicalcium salt sesquihydrate

Producto relacionado

Referencia del producto
Descripción
Precios

columna analítica

Pictogramas

Health hazard

Palabra de señalización

Danger

Frases de peligro

Clasificaciones de peligro

Carc. 2 - Repr. 1B

Código de clase de almacenamiento

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

Clase de riesgo para el agua (WGK)

WGK 3

Punto de inflamabilidad (°F)

Not applicable

Punto de inflamabilidad (°C)

Not applicable


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Certificados de análisis (COA)

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Simultaneous Spectrophotometric Determination of Atorvastatin Calcium and Ezetimibe in Tablet Dosage Form
GRB, et al.
International Journal of ChemTech Research, 1(2), 233-236 (2009)
Risheng Yang et al.
Oncogene, 39(40), 6340-6353 (2020-08-29)
Isocitrate dehydrogenase (IDH) mutation is the most important initiating event in gliomagenesis, and the increasing evidence shows that IDH mutation is associated with the metabolic reprogramming in the tumor. Dysregulated cholesterol metabolism is a hallmark of tumor cells, but the
Yanli Wang et al.
Histology and histopathology, 29(12), 1593-1600 (2014-08-01)
Statins are often prescribed for treatment of cardiovascular diseases, although there are still many patients who cannot be effectively treated by statins alone. Both probucol and cilostazol exhibit anti-atherogenic effects. In the current study, we attempted to investigate whether a
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
Shen Li et al.
Journal of atherosclerosis and thrombosis, 21(7), 648-658 (2014-03-04)
Probucol is a lipid-lowering drug that is often prescribed for the treatment of familial hypercholesterolemia. However, it is not known whether probucol can change the lesion quality of atherosclerosis. We examined this possibility using WHHL rabbits, a model of human

Questions

1–4 of 4 Questions  
  1. How is shipping temperature determined? And how is it related to the product storage temperature?

    1 answer
    1. Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf

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  2. How can I determine the shelf life / expiration / retest date of this product?

    1 answer
    1. If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
      For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
      For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
      For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/449/386/product-dating-information-mk.pdf

      Helpful?

  3. I have made a stock solitution in DMSO. At what temperature should I store it and what is the shelf life?

    1 answer
    1. The stability of this product in DMSO has not been determined. However, various sources recommend storing stock solutions in DMSO at -20°C for 1 month and at -80°C for 1 year. As a general rule, avoid repeated freeze/thaw cycles. This information has not been validated.

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  4. Buenos días, como debe reconstituirse el producto: Atorvastatin Calcium, PHR1422? Muchas gracias, Aina

    1 answer
    1. The following solubility characteristics are given in the monograph of the European Pharmacopoeia: practically insoluble in water, very slightly soluble to very soluble in ethanol (96 percent), freely soluble to very soluble in methanol, practically insoluble to freely soluble in methylene chloride, and freely soluble in dimethyl sulfoxide.

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