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1A01540

USP

(S)-GLYCIDYL PHTHALIMIDE

Pharmaceutical Analytical Impurity (PAI)

Synonym(s):

(S)-(+)-N-(2,3-Epoxypropyl)phthalimide, (S)-2-(oxiran-2-ylmethyl)isoindoline-1,3-dione, (S)-N-Glycidylphthalimide

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About This Item

Empirical Formula (Hill Notation):
C11H9NO3
CAS Number:
161596-47-0
Molecular Weight:
203.19
MDL number:
MFCD04973350
UNSPSC Code:
12352111
NACRES:
NA.24

grade

pharmaceutical analytical impurity (PAI)

Agency

USP

manufacturer/tradename

USP

application(s)

pharmaceutical

format

neat

storage temp.

2-8°C

SMILES string

O=C1N(C[C@H]2CO2)C(=O)c3ccccc13

InChI

1S/C11H9NO3/c13-10-8-3-1-2-4-9(8)11(14)12(10)5-7-6-15-7/h1-4,7H,5-6H2/t7-/m0/s1

InChI key

DUILGEYLVHGSEE-ZETCQYMHSA-N

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General description

(S)-(+)-N-(2,3-Epoxypropyl)phthalimide 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: Rivaroxaban

Therapeutic Area: Anticoagulants & Antiplatelets

For more information about this PAI, visit here.

Application

(S)-(+)-N-(2,3-Epoxypropyl)phthalimide (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.

Pictograms

Corrosion
GHS05

Signal Word

Danger

Hazard Statements

H318

Precautionary Statements

P280 - P305 + P351 + P338

Hazard Classifications

Eye Dam. 1

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

新产品

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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