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PHR1422

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Atorvastatin Calcium

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
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)
Empirical Formula (Hill Notation):
C66H68CaF2N4O10 · 3H2O
CAS Number:
344423-98-9
Molecular Weight:
1209.39
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. Y0001327
traceable to USP 1044516

API family

atorvastatin

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

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

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.

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

analytical column

Product No.
Description
Pricing

related product

Product No.
Description
Pricing

1044516

Atorvastatin Calcium, United States Pharmacopeia (USP) Reference Standard

1044527

Atorvastatin Related Compound A, United States Pharmacopeia (USP) Reference Standard

1044538

Atorvastatin Related Compound B, United States Pharmacopeia (USP) Reference Standard

1044549

Atorvastatin Related Compound C, United States Pharmacopeia (USP) Reference Standard

1044550

Atorvastatin Related Compound D, United States Pharmacopeia (USP) Reference Standard

1044571

Atorvastatin Related Compound E, United States Pharmacopeia (USP) Reference Standard

Y0001329

Atorvastatin impurity B, European Pharmacopoeia (EP) Reference Standard

Y0001327

Atorvastatin calcium trihydrate, European Pharmacopoeia (EP) Reference Standard

Y0001332

Atorvastatin impurity E, European Pharmacopoeia (EP) Reference Standard

1044593

Atorvastatin Related Compound I, United States Pharmacopeia (USP) Reference Standard

1044582

Atorvastatin Related Compound H, United States Pharmacopeia (USP) Reference Standard

PHR1873

Atorvastatin Related Compound H, Pharmaceutical Secondary Standard; Certified Reference Material

PHR1869

Atorvastatin Related Compound B, pharmaceutical secondary standard, certified reference material

PHR1872

Atorvastatin Related Compound E, pharmaceutical secondary standard, certified reference material

PHR1874

Atorvastatin Related Compound I, pharmaceutical secondary standard, certified reference material

PHR1870

Atorvastatin Related Compound C, Pharmaceutical Secondary Standard; Certified Reference Material

PHR1871

Atorvastatin Related Compound D, Pharmaceutical Secondary Standard; Certified Reference Material

PHR1868

Atorvastatin Related Compound A, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2421

1,1-Dimethylethyl (4R-cis)-6-Aminoethyl-2,2-dimethyl-1,3-dioxane-4-acetate

Y0002315

Atorvastatin calcium, CRS, European Pharmacopoeia (EP) Reference Standard

Pictograms

Health hazard
GHS08

Signal Word

Danger

Hazard Statements

H351 - H360D

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

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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)
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)
Xiao-ling Li et al.
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
Peter Norsk et al.
The Journal of physiology, 593(3), 573-584 (2015-03-17)
Weightlessness in space induces initially an increase in stroke volume and cardiac output, accompanied by unchanged or slightly reduced blood pressure.It is unclear whether these changes persist throughout months of flight.Here, we show that cardiac output and stroke volume increase
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
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