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PHR1422

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Atorvastatin Calcium

Pharmaceutical Secondary Standard; Certified Reference Material

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:
Molecular Weight:
1209.39
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to Ph. Eur. Y0001327
traceable to USP 1044516

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,[22] 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.[28]
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[28][22] using reversed-phase high-performance liquid chromatography (RP-HPLC)[28] and spectrophotometric techniques.[22]
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

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

Enter Lot Number to search for Certificate of Analysis (COA).

Certificate of Origin

Enter Lot Number to search for Certificate of Origin (COO).

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