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Merck
CN

1A00560

USP

2-Oxo Clopidogrel (Mixture Of Diastereomers)

Pharmaceutical Analytical Impurity (PAI)

Synonym(s):

(methyl 2-(2-chlorophenyl)-2-(2-oxo-2,6,7,7a-tetrahydrothieno[3,2-c]pyridin-5(4H)-yl)acetate)

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About This Item

Empirical Formula (Hill Notation):
C16H16ClNO3S
CAS Number:
109904-27-0
Molecular Weight:
337.82
UNSPSC Code:
41116100
NACRES:
NA.24
MDL number:
MFCD22371870

Key Documents

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Product Name

2-Oxo Clopidogrel (Mixture Of Diastereomers), Pharmaceutical Analytical Impurity (PAI)

SMILES string

S1C2CCN(CC2=CC1=O)C(c3c(cccc3)Cl)C(=O)OC

InChI

1S/C16H16ClNO3S/c1-21-16(20)15(11-4-2-3-5-12(11)17)18-7-6-13-10(9-18)8-14(19)22-13/h2-5,8,13,15H,6-7,9H2,1H3

InChI key

JBSAZVIMJUOBNB-UHFFFAOYSA-N

grade

pharmaceutical analytical impurity (PAI)

agency

USP

API family

clopidogrel, clopidogrel

manufacturer/tradename

USP

application(s)

pharmaceutical

format

neat

storage temp.

2-8°C

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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.

Application

2-Oxo Clopidogrel (Mixture Of Diastereomers) (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.

General description

2-Oxo Clopidogrel (Mixture Of Diastereomers) 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: Clopidogrel Bisulfate

Therapeutic Area: Cardiovascular.

For more information about this PAI, visit here.

Other Notes

Sales restrictions may apply.

pictograms

CorrosionEnvironment
GHS05,GHS09

signalword

Danger

hcodes

H314,H411

Hazard Classifications

Aquatic Chronic 2 - Eye Dam. 1 - Skin Corr. 1B

Storage Class

8A - Combustible corrosive hazardous materials

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

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