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Merck
CN

1A00010

USP

Atorvastatin Ethyl Ester

Pharmaceutical Analytical Impurity (PAI)

Synonym(s):

Atorvastatin Ethyl Ester, (ethyl (3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate)

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About This Item

Empirical Formula (Hill Notation):
C35H39FN2O5
CAS Number:
1146977-93-6
Molecular Weight:
586.69
MDL number:
MFCD00149813
UNSPSC Code:
12352200

Key Documents

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grade

pharmaceutical analytical impurity (PAI)

Agency

USP

manufacturer/tradename

USP

application(s)

pharmaceutical small molecule

format

neat

storage temp.

2-8°C

General description

Atorvastatin Ethyl Ester is a USP Pharmaceutical Analytical Impurity (PAI).
USP PAI are a product line of impurities suitable for research and analytical purposes, which help to ensure the quality and safety of medicines.
Associated Drug Substance: Atorvastatin Calcium
Therapeutic Area: Antihyperlipidemics
This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including MSDS and any product information leaflets, have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

Application

Atorvastatin Ethyl Ester (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.

Features and Benefits

USP PAI advance your early analytical R&D and process development. PAI can be used in the following applications:
1. Conduct analytical tests during early formulation feasibility studies.
2. Determine degradation impurities produced during stress studies.
3. Develop, validate, and transfer analytical methods.
4. Perform spiking studies during process R&D to demonstrate depletion upon recrystallization.
5. Record retention times and/or spectra
6. Determine relative response factors.
7. Identify unknown impurities that formed during ICH stability conditions.
8. Identify impurities that are present in the Reference Listed Drug
9. Test for and profile impurities not listed in drug substance and drug product monographs.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  

Other Notes

Sales restrictions may apply.
USP issued SDS can be found here

Pictograms

Health hazardEnvironment
GHS08,GHS09

Signal Word

Warning

Hazard Statements

H373,H411

Precautionary Statements

P260 - P273 - P314 - P391 - P501

Hazard Classifications

Aquatic Chronic 2 - STOT RE 2

Target Organs

Liver

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

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