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PHR1422

Supelco

Atorvastatin Calcium

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
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), Atorvastatin hemicalcium salt sesquihydrate
Empirical Formula (Hill Notation):
C66H68CaF2N4O10 · 3H2O
CAS Number:
Molecular Weight:
1209.39
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to PhEur Y0001327
traceable to USP 1044516

storage temp.

2-30°C

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

InChI key

SHZPNDRIDUBNMH-NIJVSVLQSA-L

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General description

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.

Application

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.
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.

Analysis Note

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

Other Notes

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.

Footnote

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.

Analyte

Description

    Atorvastatin hemicalcium salt sesquihydrate

Pictograms

Health hazard

Signal Word

Danger

Hazard Statements

Hazard Classifications

Carc. 2 - Repr. 1B

Storage Class Code

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

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

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
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
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

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